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- 2026-04-13 17:39:03
- Policy
- Roche’s Herceptin+Perjeta combo is approved in Korea
- by Lee, Tak-Sun Sep 07, 2021 05:53am
- Roche’s developed a fixed-dose combination using two of its breast cancer treatments, Herceptin (trastuzumab) and Perjeta (pertuzumab). The Ministry of Food and Drug Safety approved Roche Korea’s ‘Phesgo (trastuzumab/pertuzumab) on the 6th. Trastuzumab and pertuzumab are commonly used ingredients for breast cancer. The original brand name of trastuzumab is ‘Herceptin,’ a blockbuster drug that sold ₩69.9 billion last year according to IQVIA The original brand name of pertuzumab is ‘Perjeta.’ It sold ₩74.1 billion last year according to IQVIA. As the combination of the two drugs is also commonly used in metastatic or early breast cancer., the release of a combined, fixed-dose formulation is expected to greatly improve the dosing convenience of patients. Phesgo is a subcutaneous formulation injected in the thigh that offers faster administration than standard intravenous administration. Herceptin is available as a subcutaneous formulation, however, Perjeta is only approved as an intravenous formulation. Patients who are receiving Herceptin and Perjeta intravenously may switch to Phesgo. Also, patients who receive Phesgo subcutaneously may switch to intravenous injection of Herceptin and Perjeta. Phesgo is approved for use in combination with docetaxel in patients with metastatic or unresectable locally advanced HER2-positive breast cancer who have not received anti-HER2 therapy or chemotherapy for metastatic breast cancer. Phesgo may be used as neoadjuvant treatment in combination with chemotherapy in patients with HER2-positive, locally advanced, inflammatory, or early-stage breast cancer (tumor is greater than 2 cm in diameter). In addition, Phesgo is used as an adjuvant treatment in combination with chemotherapy in patients with HER2-positive early breast cancer who have a high likelihood of coming back. At the PHranceSCa(MO40628) clinical trial on 160 patients, 136 patients, 85% (136 participants) had reported that they prefer Phesgo over intravenous administration of trastuzumab and pertuzumab. The patients chose the reduced period of administration in the hospital as the reason for their preference. Biosimilars of Herceptin’s trastuzumab are being sold by various companies including Celltrion and Samsung Bioepis. Roche expects the release of Phesgo to provide an edge in its competition with biosimilars. Phesgo was approved by the US FDA in July last year and by the EMA in December last year.
- Policy
- Letrozole for ovulation-inducing use is not allowed
- by Lee, Hye-Kyung Sep 07, 2021 05:53am
- An application to use Letrozole (Bretra, Femara, Letrozole) as non-reimbursment has been rejected. The HIRA is receiving applications in advance for the use of non-reimbursement from the MFDS to prevent the use of drugs that lack medical grounds or are concerned about safety. According to The HIRA's recent details of "disapproval of use for non reimbursement drugs," nine cases of non-approval, including Letrozole, have been added, bringing a total of 212 cases of non-approval. The medical institutions prescribed Bretra, Femara and Letrozole applied to the HIRA to combine ovarian stimulation with reproductive gland stimulants for preservation of fertility in breast cancer patients, but were rejected due to insufficient medical evidence. Clipper Enteric Coated Tab 5mg has not been allowed for patients with GVHD symptoms, and 'Lucentis Prefilled Syringe' has been approved for retinal hematoma patients with no improvement due to laser photocoagulation and cryotherapy. Non-reimbursment applications for Botox for chronic hypothritis patients and adult peritoneal pain syndrome patients over the age of 20 have also been rejected to use "Vfend 200mg" for patients with guided inflammation suspected of fungus alone or simultaneously. An application to administer "Xeljanz 5 or 10mg" to patients with combustible skin musculitis who are 2 years old or older who do not comply with other drugs has also not been approved. The application to dilute the Isopto Atropine 1% eye drops to 0.9% Sod. Chloride in pediatric patients with myopia of minus 1.0 diopters or more between the ages of 4 and 12 has also been rejected.
- InterView
- Treatment-free remission drug for chronic myeloid leukemia
- by Sep 07, 2021 05:53am
- The introduction of the world’s first targeted anticancer drug ‘Gleevec,’ has brought a revolutionary change in the field of chronic myeloid leukemia (CML) treatment. Patients who mostly died if they were unable to receive hematopoietic stem cell transplantation, may now not only survive long-term but can maintain a high quality of life and even discuss the possibility of treatment-free remission (TFR), where a patient can maintain a state of remission in their cancer cells even after discontinuing his/her treatment. Analysis shows that the possibility of TFR is determined by the response to the drug used in the initial stages of treatment. This means that patients with a higher rate of achieving an early molecular response (EMR, BCR-ABL1 (IS) ≤10%) at 3 months of treatment are more likely to be able to discontinue drug treatment in the future. And selecting an appropriate targeted therapy is of utmost importance in achieving such a high response in the early stages of treatment. Patients diagnosed with CML may select one of the 5 first-line treatments: the 1st generation drug ‘Gleevec (imatinib),’ the 2nd generation ‘Sprycel (dasatinib),’ ‘Tasigna (nilotinib),’ ‘Supect (ladotinib),’ ‘Bosulif (bosuinib).’ Each drug has a different method of intake, effect and side effects, and therefore a drug suited for each patient should be selected according to the patient’s characteristics. The Hemato-Oncology Professor Dongwook Kim of the Uljeongbu Eulji Medical Center, who is known as the authority in CML treatment, said, “We need to search for the best drug for each patient should be identified by monitoring the patient’s condition for around a year.” Kim added, “It is the ability of the doctor to tune the regimen while maintaining a treatment response. As compliance is crucial, choosing the right drug that fits each patient’s lifestyle, as well as appropriate medication education, is also very important." Dailypharm met with Professor Kim to hear about how to select the appropriate treatment for TFR in CML. Dongwook Kim, Professor of Hemato-Onocology, Uljeongbu Eulji Medical Center, Eulji University. -Discussion of treatment-free remission (TFR) has been ongoing in CML during the past few years. I believe patients would be very interested in achieving TFR. =Around half of the 2,200 patients I treat may take the drug discontinuation approach. Around 200 patients (that participated in clinical trials) have discontinued their drugs. The patient who had stayed off the drug the longest has discontinued taking medications for 17 years since 2004. His cancer cell level had risen and fell at a low rate and then turned 0 about three times in the first year, and has had no problem ever since. -If around half of the patients have the possibility of achieving TFR, that is quite much, isn’t it? =It is. And this is now possible due to the improvement of drugs. However, the important consensus on when and how the patients should be treated. has not been reached yet. Until now, patients who received drug treatment for at least 3 years and maintained their condition for at least 2 years, and showed a sustained molecular response (level of 0 in a genetic test) discontinued their drugs. We conducted a study on discontinuing Gleevec with the 2010-2015 patient data provided by the Ministry of Health and Welfare. Data showed that around 50% of the patients who received drug treatment for at least 3 years and showed genetic test results of 0 for at least 2 years relapsed. 2 patients have died from disease progression, and one patient is being treated using a different drug. Globally, around 1% of the patients who discontinue treatment may be at risk, and around half experience recurrence. Of course, most of these relapsed patients who receive drug treatment again become better. -Patients who have a white blood cell count of 10% or less at 3 months have the possibility of TFR. What factors contribute to achieving a good response in the early stages of treatment? =Prognosis differs greatly according to the drugs you select, so accurate drug selection is important. And patients experience a lot of side effects in the first 3 months of using anticancer drugs. Therefore, you cannot use the full dose during that period, and many patients discontinue or reduce their dose. The first three months are an important period in which treatment decisions may vary depending on whether patients respond or not respond to treatments as well as compliance. A treatment-naive patient can choose from one of five targeted anticancer therapies. In choosing the one treatment, all features of the patient’s character need to be from age, gender, food preference, to his/her family medical history. The patient may choose their treatment from the scope of the information they know. I will be presenting on ‘How I select targeted anticancer therapies in CML’ at the International Conference on Hematology and Blood Disease in October. -Could you tell us in more detail what needs to be considered in determining what drug is appropriate for which patient? =You could largely consider three things. What underlying disease does the patient have? I check for diabetes, high blood pressure, high cholesterol, etc. to account for the side effects of the targeted anticancer therapies. Each anticancer drug has different side effects, and using a targeted therapy that has the side effect of increasing one’s blood pressure may treat his/her CML, but would require separate treatment for diabetes. Some drugs from blood clots or raise the cholesterol level of a patient as a side effect. Also, age is important. In particular, the prevalence of leukemia increases with age, and patients may develop CML at 70. Cells also age with humans in the aging process, and blood cells die faster with age Therefore, whether to use the 2nd or 3rd generation drugs that have much potent effect over Gleevec becomes the question. For patients in their 70s, prolonging survival to 10 or 15 years with less potent drugs that have fewer long-term side effects may be more important than being fully cured. Genetic mutations are also an important consideration. However, how the mutations affect treatment was not clearly identified, so we use the ELTS score to predict the differences in prognosis, by low-risk, moderate-risk, and high-risk patients. If we can find a gene that can predict the treatment effect using next-generation sequencing, it would become an important biomarker in the treatment of CML. -Does that mean the first-generation treatment is better for the elder patients and second-generation treatment is better for the younger patients? =Yes. Compared to Gleevec, second-generation treatment is approximately 20 times, to even 325 times in the case of Sprycel, with varying side effects. Patients who use Sprycel long term may develop pleural effusion, a condition where water fills up in the lungs. Tasigna can increase the risk of blood clots in the heart and brain by 25% in 10 years, and by 10 times in the same age range. Supect can increase blood glucose levels. Tasigna and Supect have slightly more side effects, increasing glucose levels or cholesterol levels than other drugs. Therefore, older patients that use such drugs may develop arteriosclerosis and significantly increase the probability of developing myocardial infarction, cerebral infarction, or thrombosis. So if a patient has a family history of hypertension or hyperlipidemia, the use of the two drugs I mentioned should be ruled out. This is simply looking at the side effects, and we also need to consider the presence of additional chromosomal abnormalities, additional genetic mutations, and other factors of high-risk groups, to select the drug with the lowest risk of developing side effects for each patient’s underlying condition among the second-generation drugs. Therefore, prescriptions made by each doctor for the same patient may differ by doctor. In particular, hospitals with a low prevalence and incidence rate may tend to prescribe a particular drug. Hospitals like Uljeongbu Eulji Medical Center which has a large CML patient population may be better in the selection of drugs and treatment. For example, some patients of mine came from hospitals that rarely treat CML patients after failing treatment. And I sometimes wonder why they used that drug for the patient. Also, records show many failures to treatment where the appropriate dose was not used, etc. It may also be due to side effects from other drugs that the patients had originally taken. -Also, the doing regiment for each drug is also different. This may also affect the selection of treatment according to each patient’s lifestyle. =That is true. Sprycel is taken once a day, and Tasigna or Supect is taken twice a day. Tasigna or Supect is taken in an empty stomach, so it needs to be taken 1-2 hours before or after meals, but Sprycel does not have such limitations. It has better dosing convenience as it just needs to be taken regularly once a day. In particular, patients who work night shifts or work 3 shifts, like nurses, may have trouble taking a drug twice daily. Therefore, according to each patient’s occupation and lifestyle, one of the two options – of taking drugs once or twice – may be selected. It is already a wide known fact that taking the medicine correctly without skipping is good for treatment. Discontinuing a drug can develop tolerance to the drug, and reduce the treatment effect. This is more important for drugs that are taken daily. Therefore, such a method of administration may be a serious and even critical issue for some occupations. Dosing education has become increasingly important as drug compliance is a very serious issue. A European patient group, CML Advocate, surveyed tens of thousands of patients about drug administration, and only 70% of the patients responded that they took their medication as prescribed for three days in a month. 30% did not take the drug properly for over 4 days a month. Surprisingly enough, about 60% of patients have used and survived using Gleevec since its introduction. This is in line with the medication compliance rate. In this sense, compliance to treatment is very important and discussed often. In that sense, dosing compliance of Sprycel, which is taken once a day and can be taken with or without meals, is much higher than other drugs. -In other words, making the effort to find the optimal drug for each patient according to each patient’s underlying condition and lifestyle is the most important process? =That is right. If someone asks when should we search for the right drug, I would say 1 year. I tell my patients that I would be tuning the dose for the patient while monitoring their response and side effects. It is the ability of the doctor to tune the regimen while maintaining a treatment response. And that difference is what makes one doctor more skillful than the other. One of the most frequently asked questions in lectures is what drug I would choose. And I always say, ‘There is no one drug that is best for all patients.’ We need to find the best drug for each patient.
- Company
- Tagrisso has established itself as an EGFR treatment
- by Sep 07, 2021 05:53am
- Lung cancer is the No. 1 cancer death rate among Koreans, but treatment is greatly evolving, with the 5-year survival rate more than tripling over 20 years. What had a significant impact on this was the EGFR target treatment. Targeted treatments targeting EGFR mutations have dramatically improved the overall survival period of patients. Among them, the third generation 'Tagrisso (Osimertinib)' has clearly established itself as a standard treatment for non-small cell lung cancer with current EGFR mutations. Tagrisso is a third-generation EGFR-TKI that inhibits both EGFR variations and T790M variations represented by L858R and exon 19 deficiencies. It is the only third-generation EGFR-TKI that has shown a full survival period of more than three years, which is excellent for patients with brain metastasis. AstraZeneca succeeded in the first generation of Iressa and the third generation of Tagrisso. Tagrisso's global sales reached $4.33 billion as of last year, becoming the first blockbuster drug in five years. Ironically, Tagrisso is going through all sorts of ups and downs in Korea. It's been a problem since the first registration. Since its first rapid approval in the United States in November 2015, Tagrisso has been the fifth in the world to obtain an item permit in Korea. At that time, Olita, the same third generation, was released in Korea. Tagrisso was the only third-generation drug in the world, but competed with Olita in Korea. Tagrisso was "too expensive" for the government, compared to Olita, which offered relatively low prices. In November 2016, the HIRA declared Tagrisso as a non-reimbursement drug, equivalent to the economic evaluation exception scheme. It passed the committee after three challenges, but negotiations with the NHIS were not easy. It was first listed as a secondary treatment in December 2017. Olita's development was suspended due to safety issues, and Tagrisso's quarterly sales jumped from ₩3 billion to ₩10 billion based on IQVIA. However, the Asian subanalysis data of the 2019 FLAURA 3-phase study became a problem. FLAURA is a global clinical trial that identifies Tagrisso's efficacy and safety as a primary treatment. Overall clinical results demonstrated improvement over first-generation drugs with a total survival period of 38.6 months. The problem was the result of a sub-analysis that only Asians did separately. The risk ratio (HR) of the Asian subgroup is 0.995, which is virtually no difference from the control group based on 1. AstraZeneca also submitted FLAURA China data for Chinese to reaffirm its effectiveness in Asians, but failed to pass the Cancer Drugs Benefit Appraisal Committee. Two years have passed since the first treatment indication was added, but conditions have no longer evolved since December 2017. Tagrisso's sales are steadily increasing. According to IQVIA, Tagrisso's annual sales reached ₩59.4 billion in 2018 and ₩79.2 billion in 2019. Last year, its annual sales surpassed ₩100 billion for the first time with ₩106.5 billion. It has become a global primary standard treatment. This year, Tagrisso's situation is not so good. First of all, after Olita, Yuhan's Leclaza is the second competitive drug. The UK, which was passive in primary care benefits due to its high cost, also recognized Tagrisso as primary standard treatment last year and applied the benefits. Currently, 44 countries around the world, including the United States, Britain, Germany, France, Italy and Japan, recognize Tagrisso as a primary treatment. Despite the controversy over the Asian OS, major Asian countries recognize Tagrisso as a primary treatment. Tagrisso is also applied as the first benefit in major Asian countries such as Japan, China, Taiwan and Singapore. After all, Tagrisso's benefit is an irresistible global trend. However, as two years have passed, complaints from patients are growing. It is noteworthy whether Tagrisso will be able to cross the high barrier of salary expansion amid changes in global treatment flow and demands from patients.
- Company
- Downfall of Cialis·Viagra…market taken over by generics
- by Chon, Seung-Hyun Sep 06, 2021 05:59am
- ‘Viagra,’ which had once held a commanding lead over the erectile dysfunction treatment market, is having trouble making a comeback. After being taken over by domestic generics Palpal,’ and ‘Sendom,’ it had also been outrun by another local generic, ‘Gugu.’ Lilly’s Cialis is also having trouble making a comeback due to generic competition. According to the pharmaceutical research institution IQVIA, the oral erectile dysfunction treatment market in Q2 marked ₩29.5 billion, showing a 48% YOY increase. Also, this was a 3.1% increase from the previous quarter. The erectile dysfunction treatment market had seen a reduction in sales in Q1 and Q2 of last year and had only started making a recovery since the second half of last year. In 1H last year, the reduced number of patients’ hospital visits as well as restrictions in sales and marketing due to the spread of COVID-19 had slowed down sales, but the market recovered to the previous year's level from the second half of the year. Generics from domestic companies are showing increasing influence over the market. Hanmi Pharm’s Viagra generic Palpal sold ₩5 billion in Q2, solidifying its lead in the market. Palpal’s sales had fallen 4.4% YOY, but still had a far lead over the runner-up by that makes around ₩2 billion in quarterly sales. Palpal, which was released immediately after Viagra’s patent expiry in 2012, had surpassed Viagra’s sales in Q2 2013 and Cialis’s sales in Q4 2015, then has been holding the lead in the erectile dysfunction treatment market for 6 years. Chong Kun Dang’s Cialis generic Cendom kept its 2nd place by selling ₩2.7 billion in Q2, a 5.6% YOY increase. Cendom, which was released after Cialis’s patent expired in September 2015, gradually increased its share in the market to surpass its original Cialis in Q4 2017 and Viagra in Q4 2018 and reach second place in the overall erectile dysfunction treatment market. Hanmi Pharm’s Cialis generic Gugu also marked 3rd place for the first time since its release. Gugu sold ₩2.2 billion in Q2, making a 9.5% YOY increase. Gugu’s sales had surpassed Cialis in Q2 2019 and Viagra for the first time in this term. On the other hand, originals from multinational pharmaceutical companies had not shared such positive performance in sales. Viatris Korea’s Viagra sold ₩2.1 billion in Q2 and increased 1.0% YOY, but still gave way to Gugu and lost its 3rd place in the market. This was the first time Viagra had ranked 4th in the erectile dysfunction treatment market. Viagra lost its lead in 2013 to Palpal, then became 3rd place in 2018 being outrun by Cendom. Since then, the product had stayed in its place for 2 years but then was surpassed by Gugu this year. Viagra, which had once represented the erectile dysfunction treatment market, is now selling less than half of what Palpal sells. Sales of Lilly’s Cialis also fell 6.5% YOY to mark ₩1.5 billion in Q2. The drug had held a strong lead in the market for 3 years, from Q3 2012 to Q3 2015, but had to hand over the lead in the domestic erectile dysfunction treatment market to Hanmi’s Palpal upon patent expiry. Since then, Pfizer's Viagra and Chong Kun Dang’s Cendom had sequentially exceeded Cialis’s sales. In 2018, Lilly had signed an agreement with its former sales partner, Handok, for the domestic distribution, marketing, and sales of Cialis, but saw no recovery in sales.
- Product
- Take Ibuprofen after Pfizer COVID vaccine??
- by Kim JiEun Sep 06, 2021 05:58am
- Following Tylenol, the purchase of related drugs is increasing as Ibuprofen-containing painkillers have been raised to prevent side effects of COVID vaccines in certain companies. According to outpatient pharmacies on the 6th, patients who have recently been vaccinated (Pfizer vaccines) have frequently sought Ibuprofen-containing anti-inflammatory drugs. If manufacturers have purchased Tylenol before or after COVID vaccine, they have recently been looking for Ibuprofen, particularly IBU 600mg, among Pfizer vaccine or Moderna vaccine. The reason why people only look for Ibuprofen is that videos of some specialists have been affecting online or YouTube recently. This is because some media have suggested that myocarditis, and pericarditis caused by Moderna vaccine or Pfizer vaccine should be prevented by Ibuprofen's anti-inflammatory action. Some of the experts who actually run YouTube recommend taking Ibuprofen if they find chest pain after vaccination or prevention of myocarditis, one of the possible side effects of Pfizer vaccine. Pharmaceutical companies with Ibuprofen also posted advertisements in online malls exclusively for pharmacists to take medicine for abnormal reactions such as fever and pain after vaccination. A pharmacist in Seoul said, "There are quite a few patients who get Ibuprofen 600mg," explaining on YouTube that it is good to take Ibuprofen-containing anti-inflammatory pain medication for muscle pain after getting the shot. "I dion't know how to explain this," he said. As the number of patients wishing to purchase Ibuprofen-containing anti-inflammatory painkillers before vaccination increases, many pharmacists are also explaining the related information through blogs and YouTube. Outpatient pharmacists are struggling with medication guidance to patients who believe in in information that has not been immediately confirmed. Another pharmacist in Seoul said, "Acetaminophen was initially recommended after COVID vaccine because it was believed that taking anti-inflammatory anti-inflammatory drugs could interfere with antibody formation. If there are any side effects to Acetaminophen, it is okay to take other anti-inflammatory drugs. However, it is not true to say that Ibuprofen is the only drug after the Pfizer vaccination. Another pharmacist said, "Patients mistakenly believe that Pfizer vaccine can lead to cardiomyopathy, and that Ibuprofen can cure myocarditis" However, if the patient still wants to take Ibuprofen, we have no choice but to do so.
- Policy
- Insurance benefit denied for 3 Soliris and 1 Ultomiris cases
- by Lee, Hye-Kyung Sep 06, 2021 05:58am
- Last month, ‘Soliris (eculizumab)’ and ‘Ultromiris (ravulizumab),’ which both require prior approval to be administered with reimbursement, saw mixed results in the rate of approval of their preliminary applications. In July, the Health Insurance Review and Assessment Service’s Healthcare Review and Assessment Committee deliberated reimbursement applications for Soliris, Ultomiris, ‘Spinraza inj. (nusinersen),’ ‘Strensiq inj.,’ and hematopoietic stem cell transplantation. Deliberation results that were released on the 3rd showed that 3 new applications were filed for Soliris for its atypical hemolytic uremic syndrome indication but were denied. For Ultomiris, 40 of the 41 applications filed were approved for its paroxysmal nocturnal hemoglobinuria indication. One application for Soliris was denied as the patient was deemed unsuited for administration as defined in Soliris' indication as active thrombotic microangiopathy due to observed improvement in his/her schizocytes, or has secondary thrombotic microangiopathy due to malignant tumor or use of anticancer drugs. One application for Ultomiris was denied as the patient exceeded the normal upper limit of LDH by 1.5 times and was determined ineligible for administration as paroxysmal nocturnal hemoglobinuria. Among 37 applications filed for Spinraza month, 3 were new applications. Among the 3, 2 were approved and 1 was denied. The other 34 monitored cases were all approved. One application for Spinraza’s reimbursement was denied as the patient’s symptoms and signs related to SMA were not clearly identifiable in patients less than 3 years (36months) of age. Further details of the deliberation can be found on HIRA’s business portal, biz.hira.or.kr.
- Policy
- JAK Inhibitors increases heart attack
- by Lee, Tak-Sun Sep 06, 2021 05:58am
- The health authorities warned that taking JAK inhibitors, which are used as a treatment for rheumatoid arthritis, could cause serious heart problems such as heart attacks. The target items are Tofacitinib, Baricitinib, and Upadacitinib, which have been actively used in the market recently, so medical professionals will need to examine them more closely. Sales in related markets are expected to be rapidly reduced as the FDA will restrict the drug to certain patients who do not respond to TNF inhibitors or are not drug resistant. The MFDS includes Tofacitinib, Baricitinib, and Upadacitinib, which are used in the treatment of rheumatoid arthritis. The company announced that it has distributed the Dear Health Care Professional Letter, which states that preparation of Upadacitinib can increase the risk of developing severe heart-related diseases such as heart attacks. Tofacitinib, Baricitinib and Upadacitinib are JAK inhibitors and used to treat chronic inflammatory diseases such as arthritis or ulcerative colitis, and a total of 51 items (46 companies) are licensed in Korea. The items include Pfizer's Xeljanz, Lilly's Olumiant, and AbbVie's Rinvoq SR. After checking and reviewing the contents of the U.S. Food and Drug Administration (FDA) letter on the 1st, it explained that it was necessary to provide related safety information to domestic medicine experts and consumers. The U.S. FDA reported that a large randomized trial of Tofacitinib's safety confirmed that the risk of heart attack, stroke, cancer, thrombosis and death increased when the drug was taken. In addition, Baricitinib and Upadacitinib, which have the same mechanism as Tofacitinib, are considered to carry similar risks, adding ▲ severe heart disease, cancer, thrombosis, and death risks and ▲consider the benefits and risks of patients at the initiation or continuation of the drug administration. It also announced that the use of ▲ TNF inhibitors will be restricted to certain patients who do not react or are not drug resistant. The MFDS announced that it plans to quickly take necessary safety measures for patients by reviewing domestic and foreign licensing status, and action status of the drug, including expert advice. Hospitals in South Korea stressed that the information should be checked when administering the ingredients to patients.
- Company
- Forxiga will become a basic treatment for chronic kidney dz
- by Sep 06, 2021 05:58am
- "SGLT-2 inhibitors are no longer diabetes drugs. It will be recognized by doctors of kidney medicine as a basic medicine that protects kidney function and is good for use with other medicines." Physicians expect SGLT-2 inhibitors, which have expanded their scope to kidney treatments. Choi Bum-soon, a professor of kidney medicine at the University of Catholic Medicine at Eunpyeong St. Mother's Hospital, commented on the new treatment option "Forxiga (Dapagliflozin)" that appeared in more than 20 years at an online press conference. From the left, Professor Ko Kang-ji of Korea University Guro Hospital, Professor Yang Chul-woo of Seoul St. Mary AstraZeneca's Forxiga was the first SGLT-2 inhibitor to obtain kidney medication. Forxiga, which began with diabetes drugs, was foreseen through several studies. Forxiga showed decreased cardiovascular events, kidney protection benefits, and decreased albuminuria in the DECLARE-TIMI 58 study of diabetics. The subsequent DAPA-CKD study demonstrated excellent kidney protection in patients with chronic kidney disease with a tetrahedron filtration rate of 25 to 75μg/min/1.73㎡, regardless of type 2 diabetes. "There have been few drugs to help patients not to deteriorate their kidney function," said Koh Kang-ji, a professor of kidney medicine at Korea University's Guro Medical School, at a meeting on the 30th to commemorate the addition of Forxiga chronic kidney disease. "The RAAS blocker worked, but it was 20 years ago that Forxiga was very welcome, and because it effectively reduces the pressure in the glomerulus as a different mechanism than the RAAS blocker, it can be used complementively." Professor Ko emphasized Forxiga's role in early patient treatment. "If we use Forxiga in early patients, we can effectively reduce chronic progression by increasing eGFR and we can use it effectively and safely," he said. "We need to make various efforts to increase the diagnosis rate of mild patients and quickly apply Forxiga." Choi gave advice on the proper use of drugs through Forxiga. The DAPA-CKD study found that the Forxiga administration group had a lower eGFR than the control group at the beginning. Professor Choi said, "Because the graph crossover over time, it is important for the medical team to confidently talk about patients' anxiety." "A 10% decrease compared to the baseline is a temporary phenomenon, and if more than 30% changes, we choose to temporarily stop and rewrite medicine." He added, "Since using Forxiga may cause dehydration, it is recommended to be careful of use in elderly people and patients scheduled for endoscopy and surgery the next day, and urinary tract infections are not worth worrying about." In its revised guidelines for treating heart failure announced this month, the ESC recommended SGLT-2 inhibitors such as Forxiga and Jardiance as primary treatments for patients with HFrEF. As Jardiance demonstrated its effectiveness in cardiac output coefficient-preserving heart failure (HFpEF) patients, the scalability of SGLT-2 inhibitors was further broadened. The medical team predicted that SGLT-2 inhibitors will become a major treatment option even in kidney disease. Yang Chul-woo, professor of kidney medicine at Catholic University's Seoul St. Mary's Hospital, said, "In order to live a long life as a joke, anti-hypertensive drugs such as Aspirin, Statins, and RAAS are essential, and the fourth drug is Forxiga (SGLT-2 inhibitor)." "We believe that SGLT-2 inhibitors will become a basic drug, and Forxiga is playing an important role as a leader," he said.
- Product
- Disturbance to secure inventory of Diovan and Exforge
- by Jung, Heung-Jun Sep 05, 2021 08:26pm
- Pharmacists suffered from inventory after six products, including Diovan and Exforge, by Novartis Korea, were announced to local pharmacies on the afternoon of the 1st. When there were concerns that impurities were detected, Novartis Korea explained that the quality was fine, but it was a lot release that was decided due to administrative delays. According to local pharmacies on the 1st, four products including Diovan, Co-Diovan, Exforge, and Entresto by Novartis Korea and Kotarec and Tarec by Sandoz Korea will be suspended from September. It said the lot release was suspended because it did not submit safety inspection data to the MFDS until the end of August. Upon hearing the news, pharmacists rushed to secure inventory, and all products were sold out at pharmacies-only online malls. Pharmaceutical companies immediately explained that the decision to suspend lot release is not a matter of quality. "Azido impurities were not detected in Valsartan raw materials used in that product," a Novartis Korea official said. "We have been conducting investigations for many years to confirm that there is no problem, and right after the incident, the headquarters submitted the manufacturing process verification data to major European and overseas countries and confirmed that there was no problem." Although the related documents were recently submitted to the MFDS, it took some time to confirm, so the lot release was inevitably decided from September 1. "Lot release is scheduled as soon as the reply comes," the company added. Later in the day, Novartis sent an official letter to hospital doctors and pharmacists, explaining that there was no problem with the quality of the products mentioned. A pharmacist in Seoul said, "We received an answer that we will try to release the product as soon as possible once we prepare the prescription with our inventory." "I'm glad to hear that." Another pharmacist in Gyeonggi do (in an online mall) seems to have hoarded some pharmacies because of anxiety. "I think it's going to work out faster than I thought."
