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- 2026-04-11 06:00:35
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- Kadcyla can be prescribed after registering benefit
- by Eo, Yun-Ho Nov 23, 2022 06:04am
- According to related industries, anticancer drugs such as ADC and Antibody-drug conjugate Kadcyla and CDK4/600 inhibitor Verzenio are entering the early breast cancer area in Korea. Kadcyla was already listed on the insurance benefit list in July, and the actual prescription began. The drug, which was used for the second or more treatment of HER2-positive metastatic breast cancer, has expanded access to postoperative adjunct therapy in HER2-positive early breast cancer patients with invasive residual lesions after receiving prior chemotherapy, including Taxane and Trastuzumab. The effectiveness of Kadcyla's early breast cancer was confirmed through an open-label study in phase 3 (KATHERINE). KATHERINE is a study comparing the efficacy and safety of the Kadcyla-only and Trastuzumab-based preoperative adjuvant group in 1,486 HER2-positive early breast cancer patients who were confirmed to have invasive residual lesions in the surgical site or armpit lymph nodes even after undergoing taxane and Trastuzumab-based preoperative adjuvant therapy. As a result of the study, the 3-year invasive disease-free survival (iDFS) of the Kadcyla solo administration group was 88.3%, an 11.3% improvement over the Trastuzumab solo administration group (77.0%), and a 50% reduction in the risk of disease recurrence or death. Verzenio succeeded in securing HER2-negative early breast cancer indication. This drug obtained additional approval from the Ministry of Food and Drug Safety on the 19th for HR+/HER2-, high-risk early breast cancer with lymph node-positive recurrence. The enlargement of the indication was based on the results of the Phase III clinical study cohort 1 of Verzenio's monarchE in 5,637 adult women and men at high risk of lymph node-positive type HR+/HER2- who underwent resection. As a result of the monarchE study, both IDFS (Invisible Disaster-Free Survival) and DRFS (Distant Relapse-Free Survival) at the time of follow-up 3 years showed significant improvement compared to the control group in the Verzenio administration group. The Verzenio administration group showed a 30% reduction in risk of recurrence and death within 3 years compared to the control group (88.8% of the 3-year IDFS ratio with Verzenio+endocrine therapy, 83.4% of the endocrine therapy alone), and a 31% decrease in risk of remote recurrence and death. The proportion of early breast cancer patients, which is between 0 and 1, accounts for more than half of the total breast cancer patients (as of 2018), emphasizing the importance of reducing recurrence rates through optimal treatment.
- Company
- Imjudo is expected to be introduced in Korea
- by Eo, Yun-Ho Nov 23, 2022 06:03am
- Another immuno-cancer drug with CTLA-4 inhibitory mechanism is expected to be introduced in Korea. According to related industries, AstraZeneca Korea has submitted an application for domestic permission for CTLA-4 inhibitor Imjudo, a partner in combination therapy for PD-L1 inhibitor Impinzi. The combination therapy of Impinzi and Imjudo was approved by the U.S. FDA last month as an irreversible hepatocellular carcinoma treatment. Combination therapy is the only dual immuno-cancer therapy allowed to date for the first round of liver cancer. Combination therapy is a STRIDE (Single Tremelimumab Regular Interval Durvalumab) strategy in which Impinzi is additionally administered at regular intervals every 4 weeks after one dose of Impinzi 1500 mg and Imjudo 300 mg. This combination therapy demonstrated OS benefits in phase 3 clinical HIMALAYA study, lowering the risk of death by 22% compared to the control Nexavar monotherapy. The overall survival rate in the third year was 31% in the Impinzi and Imjudo combination therapy group and 20% in the Sorafenib monotherapy group. Imjudo combination therapy recently added a lung cancer indication in the United States. In phase 3 clinical POSEIDON study on which the permit was based, the patient group receiving a combination of Impinzi, Imjudo, and platinum-based chemotherapy showed a 23% lower risk of death compared to various chemotherapy controls. The overall survival rate in the second year was 33% in the combined group and 22% in the control group. Meanwhile, Imjudo is conducting a phase 3 study of combination therapy with Impinzi in several types of cancers, including local liver cancer (EMERALD-3 study), small cell lung cancer (ADRIATIC study), and bladder cancer (VOLGA and NILE study).
- Company
- Attention focused on whether Luxturna will be reimb in Korea
- by Eo, Yun-Ho Nov 22, 2022 06:04am
- Discussions on expanding coverage of the one-shot gene therapy ‘Luxturna’ is not making much progress. Therefore, the industry’s eyes are on whether Novartis Korea’s Inherited Retinal Dystrophy (IRD) treatment Luxturna (voretigene neparvovec) will be presented as an agenda for deliberation by the Health Insurance Review and Assessment Service’s Drug Reimbursement Evaluation Committee within this year. Novartis Korea applied for reimbursement of the drug in September last year, but no news has been heard on its passage of the Drug Reimbursement Standard Subcommittee until now. However, based on the speed of progress, the drug can still be listed in the first half of next year at the earliest. By replacing the defective or defective RPE65 gene - one of the causes of IRD - with a normal gene, Luxturna restores the visual function of an IRD patient with a single administration. In other words, the drug provides a fundamental cure for IRD. After being granted a Breakthrough Therapy Designation by the FDA in 2014, the drug was approved as an orphan drug in 2016, then granted priority review and a fast-track designation in 2017. IRD is a rare disease in which vision loss occurs due to mutations in genes responsible for the structure and function of retinal photoreceptors. In addition to over 20 ophthalmologic diseases, IRD leads to vision loss and may cause complete blindness in certain patients. There are currently over 300 genes that have been identified as being associated with IRD. IRD, which is caused by the mutation in RPE65 gene, causes abnormalities in the visual cycle of the retina that converts visual information into a neural signal and delivers it to the brain. The mutation in the RPE65 gene reduces the RPE65 protein essential to the visual cycle and destroys the retinal cell, gradually narrowing the field of vision to eventually result in blindness. Meanwhile, the efficacy of Luxturna was established in a Phase III trial that was conducted on IRD patients with confirmed biallelic RPE65 mutations. Study results showed that the group of patients that received Luxturna demonstrated statistically significant improvements in their functional vision compared to the control group at one year of treatment. Using the mean score of the multi-luminance mobility test (MLMT), which evaluates the ability to complete the obstacle course at low light levels by recreating the daily walking environment, as the primary endpoint at one year of treatment, the MLMT score change in the Luxturna treatment group was 1.8 points, which was 1.6 points higher than the 0.2 points in the control group.
- Opinion
- [Reporter's view] Poor COVID-19 vaccine inducement
- by Nov 22, 2022 06:04am
- "Did you get the COVID-19 vaccine in winter? Mom and dad are the ones who should be vaccinated" The mother answered in a casual manner. "It's okay. I'm in my 60s, so I don't have to get it." "What are you talking about? You have hyperlipidemia. Get it right quickly." "It's okay. I think it'll pass lightly even if I get COVID-19." But will parents listen to the government's recommendations when she doesn't listen to their daughter easily? The government is trying to increase the vaccination rate for COVID-19. Understandably, a crisis is detected in recent COVID-19 statistics. As of the 21st, the number of critically ill patients hospitalized for COVID-19 was 465, up 14 from 451 the previous day. It is the highest level in two months since September 21 (494 people). The cumulative death toll from COVID-19 exceeded 30,000. As the number of deaths increased, the fatality rate also rose to 0.11%. As the number of confirmed cases increased due to the 7th re-pandemic, the average number of new confirmed cases per day over the past 7 days reached 52,002. In the end, it is necessary to protect the vulnerable group of COVID-19 with a vaccine, but the vaccination rates for booster shots in winter for the elderly aged 60 or older or those related to vulnerable facilities are only 17.3% and 17.6%, respectively. Eight out of 10 elderly people did not receive a divalent vaccine. The quarantine authorities set an additional vaccination period for winter from this week to the 18th of next month and started to encourage vaccinations centered on the elderly and vulnerable facilities. The goal is to complete the divalent vaccination of more than half of the elderly aged 60 or older within this period and achieve a 60% vaccination rate for vulnerable facilities. In contrast to these big goals, the incentives are fairly poor. Incentives given to individuals include temple stay discounts, cultural experience benefits such as free admission to palaces and Neungwon, and discounts when using local governments' facilities. From a child's point of view, it is unlikely that my parents will get a vaccine to go to Temple Stay or Palace. Even the old palaces and ridges are already open for free to those over 65. The public perception of COVID-19 has already changed too much. Even if you get COVID-19, you don't think it's a big deal, and rather, you're scared of the side effects of vaccines. They are not vaccinated for prevention but vaccinated for necessity. There are cases where you need to go on a trip, but you need booster shot certification, or if you don't get a vaccine, there are disadvantages. In this situation, it is hard to understand to offer incentives such as free admission to Temple Stay, which only worked last year. More effective incentives are needed. It is also necessary to promote in various ways so that the public can voluntarily seek vaccines for prevention. It is not useful to simply emphasize the justification of "vaccination." If the government's power is not enough, it can borrow the hands of pharmaceutical companies. As public advertisements are allowed for vaccines, COVID-19 vaccine developers can promote their own vaccines to increase the overall vaccination rate. The government encourages vaccination at daily briefings. It is time for an in-depth strategy to persuade the public not to end up with a cry in the air.
- Policy
- Reimb standards will be newly established for Coagadex
- by Kim, Jung-Ju Nov 22, 2022 06:04am
- Reimbursement standards for the hemophilia treatment Coagadex (Human coagulation factor X) that had been granted urgent introduction in Korea have been newly established. Also, oral eperisone hydrochloride as well as oral and ophthalmic solutions that include syrup and oral suspension forms of sodium alginate that were subject to reevaluations on their reimbursement adequacy will be applied new reimbursement standards according to their reevaluation results. The Ministry of Health and Welfare announced its partial amendment to the ‘Details on the standards and methods for application and method (pharmaceuticals)‘ and is opinion inquiry until the 24th. The new reimbursement standards are set to be applied on December 1st. First, the MOHW recognized the need for reimbursement for the hemophilia treatment Coagadex (Human coagulation factor X) in patients confirmed with hereditary Factor X deficiency and willy newly establish reimbursement standards. Patients with hereditary Factor X deficiency will be allowed the administration of Coagadex. In terms of a single administration (single dose), 40 IU/kg in patients aged less than 12 years, 25 IU/kg in patients aged 12 years or older will be allowed, with up to 4 courses recognized per visit. Under the doctor’s discretion, such as when the patient's condition is stable, up to 8 courses of administration will be reimbursable if a patient visits once every 4 weeks. If Coagadex is administered in the hospital, those administered in hospitals are also counted. However, if bleeding occurs in the patient even after administering 8 courses for 4 weeks, an additional 2 courses per visit may be covered, but the doctors’ medical opinion in the medical record needs to be attached. Also, oral eperisone hydrochloride, oral, and ophthalmic solutions including syrup and oral suspension forms of sodium alginate that were subject to reevaluations on their reimbursement adequacy this year will be applied new reimbursement standards according to their reevaluation results. Eperisone hydrochloride drugs including CHodang Pharm’s Mulex Tab will be reimbursed for painful muscle spasms associated with musculoskeletal disorders such as cervicobrachial syndrome, periarthritis, and lower back pain. Sodium alginate preparations including Taejoon Pharm’s Lamina-G solution etc will be granted reimbursement for improving subjective symptoms of reflux esophagitis. For ophthalmic solutions including syrup and oral suspension forms, a new reimbursement standard will be set under oral sodium alginate products according to the reimbursement reassessment results, and be deleted under general principles for ophthalmic solutions. The restrictions set on the number of administrations for Hanmi Pharmaceutical’s Maqaid Inj (triamcinolone acetonide) will be deleted based on approvals in Korea and abroad, textbooks, clinical practice guidelines, clinical literature, and opinion from related societies, but readministration will only be applied reimbursement when administered in intervals that exceed 3 months. Also, Hanmi Pharmaceutical’s Esomezol Cap 10mg (oral esomeprazole 10mg) will be newly listed next month and be added to the list of proton pump inhibitors. Reimbrusement standards for oral proton pump inhibitors include omeprazoles like Yuhan Losec Cap, lansoprazoles like Lanston Cap, pantoprazole like Pantoloc Tab, rabeprazoles like Pariet Tab, and esomeprazoles like Nexium Tab. However, as Esomezole DR Cap 10mg was not approved for the treatment of H.pylori infections, this indication is off-label and excluded from reimbursement. Reimbursement for Kyowa Kirin Korea’s Romiplate Inj 250μg (Romiplostim) will be extended to the treatment of refractory or relapsed aplastic anemia following immunosuppressive therapy based on approvals in Korea and abroad, textbook, clinical practice guidelines, and clinical literature. Reimbursement standards for vedolizumab injections that are applied to Takeda Pharmaceuticals Korea’s Kynteles Inj (vedolizumab) will newly include Kynteles refilled Pen Inj to account for its new listing. However, in consideration of the differences between existing formulations and the approvals (dose and usage), the evaluation method for ulcerative colitis will be changed and new standards for self-injection and long-term prescription will be set. According to the new details, considering how Kynteles Prefilled Pen Inj is a self-injection formulation, the patient should fill out a 'patient dosing diary' to monitor the administration period of the drug for the management of medical care institutions. Also, for long-term prescriptions of Kynteles Prefilled Pen Inj, a single prescription period shall be up to 2 weeks upon discharge from the hospital and up to 3 weeks for outpatient prescriptions and shall be prescribed in hospitals in principle. Patients who show no side effects and stable disease activity 24 weeks since initial administration.
- Company
- GSK Duodart can be prescribed at general hospitals
- by Eo, Yun-Ho Nov 22, 2022 06:04am
- Duodart, a prostate hypertrophy compound, has settled in general hospitals. According to related industries, GSK Korea's Duodart recently passed DC of Big 5 General Hospitals such as Samsung Medical Center, Seoul National University Hospital, Asan Medical Center, and Sinchon Severance Hospital. This drug has been applied to insurance benefits since March. Duodart's benefit target is ▲ an International Prostate Symptom Score (IPSS) of 8 or more when administered to positive prostate hypertrophy, ▲ when the size of the prostate is 30ml or higher, the occupational balance test shows moderate or higher benign prostatic hypertrophy, or the Prostate specific antigen (PSA) level meets two conditions: 1.4ng/ml or higher. Duodart is the first combination of Dutasteride and Tamsulosin introduced as a treatment for prostate hypertrophy in Korea and can be used as an oral administration of one capsule once a day to treat symptoms. It was approved by the EU and the U.S. FDA in 2010 and was approved in Korea in May last year. Combination therapy of 5α-reducing urea inhibitor (Dutasteride) and α1a-adrenaline receptor blocker (Tamsulosin HCl) is recommended in global guidelines. The complementary mechanism of two components can be expected to improve symptoms quickly and control the progression of long-term diseases. Duodart showed statistically significantly higher compliance than conventional 5α-reducing factor inhibitors and α1a-adrenergic receptor blockers Free combination through real-world data. The European Association of Urology recommends introducing 5-ARI and α blocker combination therapy from the beginning as an appropriate and effective treatment for prostate hypertrophy patients with severe or moderate lower urinary tract symptoms (LUTS) with increased risk of disease progression. The AUA also recommends the introduction of combination therapy from the beginning to treat prostate hypertrophy. Duodart demonstrated efficacy and safety through a licensed clinical combAT study evaluated against Dutasteride or Tamsulosin monotherapy. In the third month of treatment, the Duodart administration group showed a rapid improvement in symptoms similar to that of the monotherapy administration group, and from 9 months, superior symptom improvement was confirmed, and the effect was maintained until 48 months. In addition, Duodart's combination therapy was 12.6% (17.8% Dutasteride monotherapy and 21.5% Tamsulosin monotherapy) and 4.2% (5.2% Dutasteride monotherapy and 11.8% Tamsulosin monotherapy) in the progression of symptoms of prostate hypertrophy. Chung Chang-wook, a professor of urology at Seoul National University Hospital, said, "With the introduction of Duodart, among prostate hypertrophy patients currently being treated, those who had difficulty suppressing disease progression and improving symptoms with existing drug therapy can choose a new treatment."
- Policy
- Phase 3 of Fitusiran, an all-around tx for hemophilia
- by Lee, Hye-Kyung Nov 22, 2022 06:04am
- Phase 3 clinical trials of Fitusiran, a treatment candidate substance that is effective for both hemophilia A and B, are also being conducted in Korea. The Ministry of Food and Drug Safety approved a phase 3 clinical trial of Sanofi-Aventis Korea on the 18th. This clinical trial is a phase 3, single group, multi-organ, multinational clinical trial to investigate the efficacy and safety of Fitusiran prevention therapy in male severe type A or type B test subjects over the age of 12 with or without inhibitory antibodies to coagulation factor VIII or IX. In phase 3 of multinational clinical trials targeting 75 male hemophilia patients around the world, Korea has been approved for clinical trials in five patients. Clinical trials are conducted at Kangdong Kyung Hee University Hospital, Severance Hospital, and Inha University Hospital. The Fitusiran global clinical trial was voluntarily suspended by Sanofi in October 2020 after non-fatal symptoms of thrombosis were found in phase 3 clinical trial participants. Sanofi also stopped all studies in September 2017 when one patient died of thromboembolism in the brain during phase 2 clinical trials. Hemophilia is a congenital hemorrhagic disease caused by a lack of blood clotting factors, and the incidence rate is estimated to be around one per 10,000 people. Depending on the type of insufficient coagulation factors, it is divided into two types: hemophilia A and hemophilia B, with type A accounting for 80% of the total and type B accounting for the remaining 20%. Fitusiran is a small interference RNA (siRNA) treatment that targets antithrombin, which is a treatment for hemophilia type A and type B patients and promotes thrombin production by lowering the level of antithrombin to prevent hemophilia's hemostasis and bleeding. Currently, Hemlibra, which is used for hemophilia type A, ranks first in the hemophilia treatment market, and Sanofi and Novonordisk's Concizumab are the development treatments used for both hemophilia type A and type B patients.
- Policy
- Gov't declines preferential pricing for innovative drugs
- by Lee, Jeong-Hwan Nov 21, 2022 05:56am
- Complaints are rising in various areas of the pharmaceutical industry with the Ministry of Health and Welfare maintaining its position that preferential pricing for new drugs manufactured by Korea Innovative Pharmaceutical Companies cannot be introduced in practicality due to issues including trade conflict, NHI finances, etc. The industry is complaining that the Ministry of Health and Welfare taking too much of a protective stance rather than focusing on preparing preferential pricing measures based on the fact that not only domestic pharmaceutical companies but US and UK companies are accredited as Korea Innovative Pharmaceutical Companies. On the 20th, MOHW reiterated its position that authorities must play caution in providing preferential pricing measures for Korea Innovative Pharmaceutical Companies and drugs that use domestically manufactured APIs, etc, virtually reaffirming its plan on the non-introduction of such policies. Although a clause for providing preferential pricing to Korea Innovative Pharmaceutical Companies had been prepared as of December 11th, 2018 under the Special Act On Fostering and Support of Pharmaceutical Industry, the government had also expressed practical difficulties in its implementation as providing pricing support for specific pharmaceutical companies, despite its legal basis, can lead to trade conflict. Regarding the enactment of subordinate statutes, the MOHW said it agrees with their necessity, but would need to consider whether it conforms to the international trade order. The ‘Premium drug pricing system for global innovative new drugs,’ which had been announced on July 7th, 2016 to provide preferential treatment for drugs developed by such companies, had been deleted in December 2018 as a discriminatory factor as a result of negotiations on amendments and modifications of the US-Korea (KORUS FTA). However, the domestic pharmaceutical industry stressed the need to promptly introduce a preferential pricing policy for innovative new drugs based on the fact that the criteria for accrediting innovative pharmaceutical companies are not limited to domestic companies. Also, the demand for preferential pricing of innovative new drugs by domestic pharmaceutical companies has been increasing further as MOHW Minister Kyu-Hong Cho stated that “further phased price cuts are deemed necessary as the price of generics are more expensive in Korea than overseas” regarding price cuts for generic drugs that are considered the basis of Korea’s pharmaceutical industry at the NA audit this year. The main reason for complaints raised by domestic pharmaceutical companies is that the Korean government is passive in preparing preferential treatment for innovative new drugs while concentrating on reducing the generic drug price. Also, the industry pointed out that as multinational pharmaceutical companies are also selected as Korea Innovative Pharmaceutical Companies in addition to domestic pharmaceutical companies, the policy should not be considered as being favorable for domestic pharmaceutical companies. Three multinational pharmaceutical companies – AstraZeneca Korea, Janssen Korea, and Korea Otsuka Pharmaceutical - have been accredited as Korea Innovative Pharmaceutical Companies. In other words, if the MOHW continues to solely pursue the plan to lower generic drug prices without specific preferential treatment or preservation measures, the concern of domestic pharmaceutical companies is likely to continue to deepen. A domestic pharmaceutical company official pointed out, “In every NA audit, the government had repeatedly promised policies to support drive new drug development, but no mechanism for preferential treatment for new drugs has been established as of now. The MOHW seems to have no plans to provide preferential treatment for drug prices and only have plans to lower generic drug prices." The official said, “If preferential pricing for Korea Innovative Pharmaceutical Companies may cause a trade dispute, the government should also separately contemplate measures to resolve the issue as well. Foreign pharmaceutical companies are also accredited as Korea Innovative Pharmaceutical Companies in addition to Korean companies.” Another official from a different pharmaceutical company in Korea also said, “The answer that the government would provide preferential treatment for new drugs after reviewing the international trade order and its financial impact on health insurance finances seems to mean that it will provide no preferential treatment. If this measure cannot be implemented, other measures to provide measures to preserve the drug price. The government has always been opposed to the request to preserve drug prices as well.” The official added, “If the government only formalizes the price cut of generic drugs and provides no response to the request for preferential treatment, reevaluation, or exceptions for the other drugs, domestic pharmaceutical companies will inevitably become more dissatisfied. The current response that no preservation or preferential treatment can be provided to domestic drugs because of NHI finances is quite irresponsible.” Meanwhile, members of the National Assembly's Health and Welfare Committee have also been demanding a drug price preservation policy every year, but it seems difficult for the NA to make further requests with the government continuing to repeat its principled answer. Following last year, members of the NA Health and Welfare Committee Rep. In-Soon Nam, Min-Seok Kim of the Democratic Party of Korea, and Rep. Jong-Seong Lee, Jong-Hean Baek, called for measures to provide preferential treatment for new drugs to foster Korea’s domestic pharmaceutical industry at this year’s NA audit.
- Company
- Evrysdi can be prescribed with non-reimbursement
- by Eo, Yun-Ho Nov 21, 2022 05:56am
- Evrysdi, an eating spinal muscular atrophy treatment, can be prescribed at hospitals and is still non-reimbursement. According to related industries, Roche Korea's Spinal Muscular Atrophy treatment passed through D.C. at medical institutions such as Severance Hospital, Seoul National University Hospital, Yangsan Pusan National University Hospital, and Yongin Severance Hospital. Evrysdi, which was approved in Korea in November 2020, was first approved for "adult and infant SMA patients for more than 2 months." On top of that, the U.S. recently expanded the scope of administration to infants under 2 months of age in the United States. Evrysdi, the first oral option as an SMA treatment, has the advantage of being able to be customized according to age and weight. The process of registering insurance benefits is still sluggish. Solidarity Against Disability Discrimination issued a statement last month when Zolgensma's benefit was applied, calling on the HIRA to abolish the criteria for suspension of Spinraza's benefit, the same SMA treatment, and implementation of Evrysdi discussions as soon as possible. Evrysdi points out that SMA patients are emerging in the blind spot of therapy as the Korea Appraisal Board continues to withhold discussions on benefits just because they will discuss them in the future in line with the adjustment of Spinraza's application standards. Currently, the SMA area lists Biogen's Spinraza and Novartis' Zolgensma. Evrysdi proved its efficacy through a FIREFISH study conducted on infants of 2 months to 7 months and a SUNFISH study conducted on children and adults aged 2 to 25. In SUNFISH conducted in 180 SMA type 2 or type 3 patients, Evrysdi demonstrated improvement in motor function at 12 months when measured with MFM-32, an exercise function evaluation measure. In addition, in FIREFISH conducted on infant SMA patients with type 1 2 to 7 months of age, 88% of patients who received Evrysdi for 2 years continued to survive without a ventilator for 2 years. During the two-year period, 59% of infants could sit unaided for at least 5 seconds on a BSID-III basis, which measures total infant and infant development exercise. In addition, 65 percent of infants were able to hold their throats for a year, 29 percent were able to turn themselves over for a year, and 30 percent were able to stand using support.
- Policy
- Label for rosuvastatin to change following ticagrelor
- by Lee, Hye-Kyung Nov 21, 2022 05:56am
- The drug-drug interaction label for rosuvastatin drugs that are used to treat hyperlipidemia including AstraZeneca’s ‘Crestor’ will be changed. The drugs that affect rosuvastatin are ticagrelor drugs including AstraZeneca’s antiplatelet drug ‘Brilinta.’ The labeling change for ticagrelor has been preannounced by the Ministry of Food and Drug Safety in August and is set to be made on December 2nd. The labeling changes for rosuvastatin in line with the changes made for ticagrelor will also be applied after collecting opinions until December 2nd. According to the planned changes that will be made, the phrase ‘Ticagrelor can cause renal insufficiency and may affect renal excretion of rosuvastatin, increasing the risk for rosuvastatin accumulation’ will be newly added in the drug-drug interaction label of both the monotherapy and combination therapies of rosuvastatin. In some cases, co-administered ticagrelor and rosuvastatin led to a renal function decrease, increased CPK level, and rhabdomyolysis. Therefore, renal function and CPK control are recommended while using ticagrelor and rosuvastatin concomitantly. The MFDS prepared the label change based on European Medicines Agency’s safety review results on rosuvastatin. Items approved in Korea that contain rosuvastatin include 974 items including Crestor, Kuhnil Biopharm’s ‘Rosucande Tab,’ Kims Pharmaceutical’s ‘Rosuvac Tab,’ Ahngook New Pharm’s ‘Newsuvatin Tab,’ HK Inno.N’s ‘Vivacor Tab,’ Novartis Korea’s ‘Rosuco Tab,’ and Abbott Korea’s ‘Lypsta Tab.’
