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- 2026-04-13 23:21:32
- Company
- Entry of generics halt Nexavar’s sole lead in liver cancer
- by Kim, Jin-Gu Aug 30, 2021 05:55am
- Product image of Bayer’s hepatocellular carcinoma treatment NexavarNexavar (sorafenib), which had been leading the liver cancer treatment market for over 10 years since its launch, has handed over its lead to ‘Lenvima (lenvatinib)’. This was a combined result of Nexavar’s drug price falling 30% due to the launch of its generics, and the rise in sales of its competitor Lenvima. Nexavar’s position in the liver cancer treatment market is expected to shrink further while competing with its generics as more products awaiting to enter the market. ◆1H sales of Nexavar drop from ₩10.3 billion to ₩5.6 billion… Impact of drug price cut According to the pharmaceutical market research firm IQVIA on the 28th, Bayer’s hepatocellular carcinoma treatment Nexavar recorded ₩5.6 billion in sales in 1H 2021. Compared to the ₩10.3 billion it earned in 1H of the previous year, sales fell 45%. In the same period, sales of Eisai’s Levima increased by 27%, from ₩ 5.7 billion to ₩7.2 billion. With sales of Nexavar plummeting and Lenvima significantly increasing, their shares in the market also changed. This is the first significant change observed in the market in 13 years since Nexavar was first used as a treatment for liver cancer treatment and 3 years since Lenvima was launched in Korea. Bayer had originally launched Nexavar in Korea in 2006 as a treatment for kidney cancer. Then, in 2008, it added the indication for hepatocellular carcinoma. The drug began to make real sales in 2011 after reimbursement was extended to the indication. Nexavar enjoyed exclusivity in the liver cancer treatment market for 10 years until Lenvima's release in 2018, earning over ₩20 billion in sales annually. However, the competition began after Lenvima was approved for reimbursement in 2019. In the beginning, Nexavar overpowered the market because the drug sequentially allows Stivarga and Cabometyx as follow-up treatments. However, Lenvima gradually increased its influence in the market and narrowed the gap with Nexavar with its improved clinical data. In February, Nexavar faced a direct hit, as its insurance ceiling price was cut by 30%. The government reduced Nexavar’s drug price ex officio by 30%, from the original ₩18,560 to ₩12,992, because Hanmi Pharmaceutical successfully launched its generic after overcoming Nexavar's patent. Quarterly sales of Nexavar and Lenvima (Unit: ₩100 mil, Data: IQVIA) ◆Competition intensifies in the market with the entry of Tecentriq and Nexavar generics Also, Nexvar's sales are expected to continue to fall for the time being. First, the drug price will be cut once more in early next year. Korea’s insurance drug price system mandates that the price of an original drug should be reduced by 30% at the time of a generic drug's release, then to 53.55% of the previous price 1 year after the generic is released. In addition, Roche's immuno-oncology treatment Tecentriq (atezolizumab) is about to enter the first-line treatment market for hepatocellular carcinoma. In February of this year, Tecentriq, in combination with Avastin, passed the Health Insurance Review and Assessment Service's Cancer Disease Deliberation Committee as a liver cancer treatment. This means that reimbursement for Tecentriq is imminent. If approved, Tecentriq's entry into the liver cancer treatment market will only further narrow Nexavar's position in the market. Also, generic competitors await Nexavar. Hanmi Pharmaceutical overcame the patent for Nexavar and was approved for its generic Soranib. In the 5 months since release in February, the drug successfully landed ₩200 million in sales. Hanmi Pharm’s period of exclusivity rights expired at the end of July. However, the possibility that competitors from companies such as Kwangdong Pharmaceutical, which is also challenging Nexavar with its own generics, will add on to the competition remains. Kwangdong Pharmaceutical began a bioequivalence test for its generic last year.
- Policy
- Korean pharmas are pursuing various SGLT-2 combos
- by Lee, Tak-Sun Aug 30, 2021 05:55am
- Jeil Pharmaceutical HQ located in Seocho-gu, Seoul Companies are busy developing combination therapies combining the latest diabetes treatment, SGLT-2 inhibitors, with existing diabetes treatment. In particular, domestic companies that are eyeing the SGLT-2 market have been testing various combinations for commercialization. On the 26th, the Ministry of Food and Drug Safety approved the Phase III clinical trial protocol for ‘JT-001’ that was submitted by Jeil Pharmaceutical. The trial will be conducted to assess the safety and efficacy of additionally administering JT-001 in combination with dapagliflozin+metformin in type 2 diabetes patients inadequately controlled by the dapagliflozin+metformin combination. JT-001, or pioglitazone hydrochloride, belongs to a type of existing diabetes drug class called TZD (thiazolidinediones). Therefore, the trial's purpose is to assess the safety and efficacy of administering pioglitazone hydrochloride in combination with dapagliflozin+metformin, to ultimately commercialize the 3-drug combination. Recently, companies have been first identifying the safety and efficacy of their combination drugs through Phase III trials, then conducting bioequivalence tests comparing the combined use of individual ingredients and the combination drug through Phase I trials. The Phase III first then I approach is backward compared to the conventional method where the trials are conducted sequentially, from Phase I to II, then III. This method can be applied because new combination drugs are exempt from Phase II trials, and the Phase I (bioequivalence test), and Phase III (efficacy test) are different in nature. Even when the drug fails to demonstrate bioequivalence in the Phase I trial, the drug may still receive approval if it demonstrates its efficacy in the Phase III trial. Jeil Pharmaceutical’s JT-001 has currently only received approval to conduct the Phase III trial. SGLT-2 inhibitors block the SGLT2 transporter that is in charge of glucose reabsorption and excrete glucose through the urine for an antihyperglycemic effect. Major SGLT-2 drugs are Forxiga, Suglat, and Jardiance. These drugs, which are all new drugs developed by foreign pharmaceutical companies, have been leading the latest diabetes treatment trend. Domestic companies are also busy developing latecomers to join in the SLGT-2 inhibitor market. Some companies, like Daewoong Pharmaceuticals, are pursuing new drug development with new ingredients like enavogliflozin, etc., but most are developing modified or combination drugs using existing ingredients. This is because it is easier to avoid patents with incrementally modified drugs or combination drugs. Like Jeil Pharmaceutical, Chong Kun Dang is also developing an SGLT-2 inhibitor + TZD combination drug. The company is conducting a clinical trial on a combination drug that combines its self-developed TZD class lobeglitazone (brand name: Duvie) with an SGLT-2 class empagliflozin, and metformin. Also, approval for SGLT-2+DPP-4 combination drugs is imminent. Dongkoo Bio&Pharma had applied for the approval of a combination drug combining the SGLT-2 class dapagliflozin with the DPP-4 class sitagliptin to the Ministry of Food and Drug Safety in the first half of this year. As Dongkoo Bio&Pharma developed the drug jointly with other pharmaceutical companies, more products are expected to file for approval. Also, LG Chem is conducting a clinical trial to commercialize its DPP-4 inhibitor gemigliptin and SGLT-2 inhibitor dapagliflozin combination, and Aju Pharm is also conducting the same trial on a linagliptin+dapagliflozin combination Once commercialized, pharmaceutical companies expect a strong performance from the combination drugs as the individual ingredients contained in the drugs are all blockbuster drugs that are commonly used in combination in practice. However, with so many fixed-dose combinations drugs to come, and the preference for originals and combined prescription of individual drugs still strong, whether the performance of the to-be-released combination drugs will be strong remains to be seen.
- Policy
- The patent for Breast Cancer Therapy Affinitor has been clos
- by Lee, Tak-Sun Aug 30, 2021 05:55am
- The patent suit for Affinitor, which was conducted by Novartis and Kwang Dong, was finally closed due to the plaintiff's withdrawal. As a result, Kwang Dong and Samyang Biopharm are able to market more actively. According to the industry on the 26th, the lawsuit against the use patent of Afinitor, which has been filed since March last year due to Novartis' complaint, ended with the withdrawal of the plaintiff's complaint on the 19th. Novartis filed a complaint in January last year asking for cancellation of the Intellectual Property Trial and Appeal Board's claim for invalidation of the Afinitor patent filed by Kwang Dong. Kwang Dong first filed a claim for invalidation of the patent in March 2016, and finally won in about five years. The use patent for Afinitor was due to end in February next year. After is a drug used in anti-cancer drugs such as breast cancer. Sales based on IQVIA last year were ￦14.9 billion. It is currently licensed as generics for Afinitor by Kwang Dong and Samyang Holdings. Kwang Dong's Erinito 10mg was approved in March 2019 and Erinito 5mg in March last year. In July last year, Samyang Holdings' Everose 10 mg, 5 mg and 2.5 mg were licensed As the patent lawsuit is closed, both companies are expected to focus their efforts on product marketing without any burden of patent infringement. Given that there are only three products with the same ingredient, it is expected that sales of generics will increase. On the other hand, Novartis, the original company, is expected to come up with various strategies to check out generic companies.
- Company
- Cosentyx begins competition in the market
- by Aug 30, 2021 05:54am
- As Interleukin-17 (IL-17) sanctions enter the primary biological formulation benefit range for psoriasis arthritis, they will compete in earnest with TNF-α inhibitors. Cosentyx (Secukinumab) of Novartis expanded health insurance benefits from psoriasis arthritis to primary biological sanctions on the 1st. Cosentyx can be used if it meets certain conditions among active and progressive arthritis patients who are not effective in treating two or more types of DMARDs or who are difficult to treat due to side effects. The condition is for patients with three or more compressed joints and three or more edema joints. Previously, IL-17 regulations were paid only when TNF-α inhibitors were used first and used as secondary biological regulations in patients with insufficient response or difficulty in treatment due to side effects. This expansion allows Cosentyx to be prescribed in a position equivalent to the TNF-α regulation. Of course, it is not easy to compete with TNF-α drugs, which have long been widely used for autoimmune diseases such as psoriasis arthritis. In response, the interleukin formulation was intended to demonstrate superiority with head-to-head clinical trials. EXCEED studies, phase 3 clinical trial of Cosentyx, are typical. The effectiveness and safety of Cosentyx was compared as a control group with the representative TNF-α formulation, Humira (Adalimumab). The main evaluation item is ACA20 at week 52 of treatment, which represents a 20% improvement in arthritis. Clinical results show that the Cosentyx group and the Adalimumab group had a 67% to 62% ACR20 ratio, which resulted in Cosentyx absolute value, but did not satisfy statistical significance (p=0.0719). However, the rate of improvement in Psoriasis symptoms (PASI 90), a secondary evaluation variable, was significantly different from 65% to 43%. We also demonstrated significant improvements in the integrated evaluation variables ACR50 (more than 50% improvement in arthritis) and PASI100 indicators by 31% versus 19%. The percentage of patients who maintained treatment until the 52nd week was 86% to 76%, which was higher in Cosentyx. Shin Ki-chul, a professor of rheumatology at Boramae Hospital, said at a Cosentyx conference on the 25th, "Although ACR20 did not satisfy the statistical significance, it was different in ACR50 and it was more effective in ACR70. Of course, the primary indicator was set to ACR20 and the clinical design." The advantage of Cosentyx, which differentiates itself from conventional TNF formulations, is that it comprehensively treats the major symptoms of psoriasis arthritis. Cosentyx may be a priority consideration, especially in patients with spondylitis. International treatment guidelines have also changed accordingly. GRAPPA (Psoriasis and Psoriasis Arthritis Research and Assessment Group), a renowned international research group, recommends Cosentyx as a primary biological agent in the treatment of psoriasis arthritis, skin psoriasis, hand and toe psoriasis. The EULAR also suggested Cosentyx as the primary biological agent in arthritis and spinal arthritis in late 2019 and stated that it could be preferred over TNF inhibitors when there are related skin symptoms such as psoriasis. "The fact that IL-17 inhibitors are more effective in skin psoriasis than TNF preparations is now somewhat established. In addition, Cosentyx has the advantage of being able to control the dose from 150mg to 300mg. "It is reasonable to consider Cosentyx as the primary biological agent for psoriasis and other symptoms such as psoriasis." Competition with Taltz, which entered the primary benefit range at the same time, is also noteworthy. Paul Thomas, a medical director at Novartis Korea, said, "The study confirmed that Cosentyx is less likely to develop immunogenicity." Humanized antibodies are those that increase the similarity to human antibodies. Furthermore, human antibodies have no animal-derived parts, minimizing immunogenicity. Cosentyx is also attempting to enter primary biological sanctions in ankylosing spondylitis. Park Hye-yoon, executive director of the Novartis Transplant Immunity and Skin Disease Division, said, "We are trying to deliver good news in Korea as Cosentyx is being paid in most major countries such as the U.S., Canada, Japan and Australia under the primary regulation of ankylosing spondylitis."
- Policy
- Regulation of COVID-19 vaccines is imminent
- by Lee, Jeong-Hwan Aug 27, 2021 05:59am
- As the "Special Act on the Development of Public Health Crisis Response Medical Products and the Emergency Supply" sub-enforcement decree passed the Regulation Reform Committee preliminary review, regulations and management such as COVID vaccines will be strengthened. The MFDS plans to conduct a follow-up investigation of the public health crisis-response vaccine announced in April, report methods of abnormal cases, emergency production and import orders, and establish regulations on distribution improvement measures. On the 25th, the Regulation Reform Committee judged all four regulatory provisions as "non-critical regulations" as a result of the MFDS' preliminary review of the Enforcement Decree of the Special Act on Public Health Crisis Response. If non-critical regulations are determined in the Regulation Reform Committee preliminary review, the relevant ministries can proceed with enactment or revision of the regulation reform committee without submitting, deliberating, or deciding on the regulation reform committee's main review. When classifying important regulations, the regulation reform committee or the main committee's review must be passed before the legislation and revision of the relevant ministries can be made. Critical regulatory standards include the cost of more than ₩10 billion a year to be borne by regulated groups and citizens, or excessive levels of regulation in light of international standards. The Enforcement Decree of the Special Act on Medical Products for Public Health Crisis Response determined by the Regulation Reform Committee as a non-critical regulation is a regulation established by ▲ tracking investigation and reporting methods ▲ registration of medical products subject to tracking investigation ▲ emergency production and import order and ▲ distribution. Specifically, the method of tracking investigation and reporting abnormal cases is applied when it is recognized that it is necessary to check whether abnormal cases occur for a certain period of time. Based on the special law, the method of tracking investigation reporting and the method of reporting abnormal cases may be specified in detail. Statistics can be aggregated as abnormal cases and side effects can be reported through follow-up investigations after permission to market and treatments. The registration of medical product details subject to follow-up investigation is a provision that allows the identification of the occurrence of abnormal cases when conditional item permission is obtained as a crisis-response medical product. Conditional licensed products can be designated and managed as targets for follow-up investigation, so sales and supply details can be specifically determined from administration and registration. The emergency production and import order procedure stipulates the contents of an emergency production and import order to secure the quantity of medical products necessary for responding to public health crisis. The regulation allows those notified of emergency production and import orders to establish a production and import plan, submit it to the director of the MFDS, and report the results. The distribution improvement measures procedure stipulates necessary measures for each person when determined to be subject to distribution improvement measures to respond to public health crises. The MFDS is expected to take steps to enact enforcement ordinances that have been judged non-critically by the regulatory reform committee. Regarding the need to introduce the regulations, the MFDS said, "It is urgent to introduce a supply system to manage the manufacture, import, and distribution of medical products necessary for the spread of COVID-19." The MFDS added, "The government should intervene to support the rapid development and emergency supply of medical products such as vaccines, treatments, masks, hand sanitizers, diagnostic kits, and artificial disposal."
- Opinion
- [Reporter’s View]Reimbursement of antidiabetic combos
- by Eo, Yun-Ho Aug 27, 2021 05:59am
- After 3 long years, discussions on extending reimbursement of SGLT-2 inhibitor combos are expected to begin. In September, the Health Insurance Review and Assessment Service will hold an expert meeting to discuss approving reimbursement for combination use of the two classes of oral antidiabetics: DPP-4 inhibitors and SGLT-2inhibitors. ‘Recognizing the expected efficacy of two drugs with the same MOA.’ Acknowledging this class effect has been a long-discussed dilemma in the industry. The opinion has been divided among the HCPs, and the interest of individual pharmaceutical companies also differ. The conclusion was to take on the agenda ‘case by case.’ It is not necessarily a question that requires a fixed answer. The decision made by the prescribing doctor based on his or her experience and medical knowledge is, of course, most important. However, for the SGLT-2 inhibitor issue, the problem lay in the consistency of the decisions. For some classes, the class effect was recognized regardless of the drug’s indications and applied the same reimbursement standards, while reimbursement for other classes was approved for different scopes by each product. In 2013, the Korean Diabetes Association had played a leading role in extending reimbursement to cover the combined use of DPP-4 inhibitors and Thiazolidinedione (TZD) class drugs, insisting on the justification and necessity of its reimbursement. Clinical experience and expert judgment were emphasized rather than the fiscal impact, and the government accepted the reimbursement extension based on the disease characteristics and drug use experience. What has changed since then? In 2018, the academic community had mixed opinions regarding SGLT-2 inhibitors, which put discussions on reimbursing the combined use of the drug on hold. Many drugs were at stake, as this not only affected SGLT-2 inhibitors like ‘Jardiance(empagliflozin),’ ‘Forxiga(empagliflozin),’ ‘Suglat (ipragliflozin), ‘Steglatro (ertugliflozin),’ but also the many DPP-4 inhibitors including ‘Januvia (sitagliptin), ‘Galvus (vildagliptin),’ ‘Tradjenta (linagliptin),’ ‘Gemiglo(gemigliptin),’ etc. However, the changes that followed were encouraging. In April last year, the academic society saw consensus and submitted the opinion that expanding reimbursement is necessary. In August last year, the Ministry of Health and Welfare announced that it will simplify the indication listing method of antidiabetic drugs from by substance to ▲monotherapy or ▲combination therapy. Now the baton is in the hands of the insurance authorities. Time has already passed, and dissatisfaction still does exist around primary medical institutions. As it is a prescription drug, it is also true that the issue should be considered carefully, and a cautious approach is needed. However, if the class effect is to be finally acknowledged, this could be the perfect opportunity for the stakeholders to reach a consensus on ‘the time or amount of prescription required to accumulate sufficient prescription experience.’
- Company
- Shingles vaccine market overwhelmed by COVID-19… drops 60%
- by An, Kyung-Jin Aug 27, 2021 05:59am
- The domestic market for shingles is shrinking at a fast pace. With vaccinations for COVID-19 ongoing in earnest from earlier this year and the new ‘Delta variant’ intensifying the resurgence of COVID-19 cases, sales of the two shingles vaccines have dropped together. According to the pharmaceutical research institution IQVIA on the 26th, the shingles vaccine market in Q2 this year was ₩9.2 billion, a 59.1% YOY decrease from the ₩22.6 billion in the same period of the previous year. Sales had decreased 53.0% compared to the ₩19.6 billion in Q2 2019. Cumulative sales in 1H of this year have also decreased 42.2% from the previous year to record ₩20.1 billion. The shingles vaccine market in Korea consists of two products – MSD’s ‘Zostavax’ and SK Bioscience’s ‘SKYZoster.’ Its market had grown rapidly with the introduction of ‘SKYZoster’ in 2017 that broke the monopoly held by ‘Zostavax.' The local vaccine ‘SKYZoster’ had gradually increased its influence in the market, to rise and record ₩27.9 billion in Q4 2019. However, this shingles vaccine market that was once on a roll, is riding a rollercoaster of ups and downs after the COVID-19 pandemic. In Q1 last year, when COVID-19 started to spread, the market sales had halved to ₩12.2 billion. In Q2 of the same year, the market showed some signs of recovery, recording ₩22.6 billion, but then started falling again to ₩20.3 billion in Q3 and ₩17.3. billion in Q4. Entering this year, the drop became steeper, to record the lowest-ever sales since the two-drug competition structure was established in the market. The industry pointed out that the shingles vaccine market and other vaccine markets are more vulnerable to external factors such as pandemics, etc. than the chronic disease treatment market. Such vaccines are used to prevent a disease rather than be used in emergencies, therefore, the spreading reluctance to visit medical institutions naturally leads to a reduced vaccination rate. Full-scale inoculations with COVID-19 vaccines developed by multinational pharmaceutical companies including Pfizer and BioNTech, AstraZeneca, and Janssen have started earlier this year and have affected the decrease in the number of people receiving other vaccines. According to the Korea Disease Control and Prevention Agency, as of midnight on the 25th, a total of 26,701,704 people have received their first dose of a COVID-19 vaccine. This is around 52.0% of the total population in Korea. With the social atmosphere prioritizing COVID-19 vaccinations, Most of the vaccine market for adults, including the one for the shingles vaccine, is experiencing a slump. The two types of shingles vaccines -‘Zostavax’ and ‘SKYZoster’ – have shown a similar trend in their distribution of quarterly sales since last year. ‘Zostavax’ sold ₩5.4 billion in Q2 last year, which is a 57.9% YOY decrease from the same period of the previous year. This is also a 17.0% drop from the previous quarter, during which ‘Zostavax’ sold ₩6.5 billion. This year's cumulative sales in 1H were ₩11.9 billion, a 40.8% decrease from the previous year. Starting this year, MSD’s ‘Zostavzx’ has been marketed and sold by HK Inno.N in Korea. SKYZoster’s sales dropped 60.8% YOY to record ₩3.8 billion in Q2 this year. This is the lowest ever performance shown for the product other than in Q4 of 2017, immediately after its release. Cumulative sales of the first half of this year were ₩8.2 billion, a 44.2% decrease from the previous year. Not only in sales but SKYZoster’s market influence, which had skyrocketed ever since its release, has also decreased due to the pandemic. Based on cumulative sales of 1H, SKYZoster’s share in the market has decreased 1.4%p YOY from 42.2% to 40.8%. SK Bioscience expected sales of SKYZoster to recover in 2H with the increase of people who completed COVID-19 vaccinations and the start of the flu vaccination season.’ Also, another competitor is soon to be introduced to the domestic shingles vaccine market, forewarning more changes to come. Earlier this year, GSK has applied for the marketing authorization of its shingles vaccine, ‘Shingrix,’ to the Ministry of Food and Drug Safety. ‘Shingrix’ has been approved and is being sold in major countries around the world since 2017, when it was first approved by the U.S. Food and Drug Administration. Due to its high demand, the vaccine has been met with shortages in stock abroad. If sold in Korea, GSK’s ‘Shingrix’ in Korea may intensify competition and become a game-changer in the market.
- Policy
- RSA refund should be differentiated by income
- by Kim, Jung-Ju Aug 27, 2021 05:59am
- Currently, it has been suggested that Korea should apply RSA's refund flexibly by differentiating it according to income. It is suggested that the government should reduce the refund of high-income earners according to the income distribution and strengthen the guarantee of high-weakness by operating the refund of low-income earners in the form of a pre-deductible system. Ahn Jung-hoon, a professor of health convergence at Ewha Womans University, made the announcement at a policy forum hosted by Kang Sun-woo today (the 25th) under the theme of "the performance of strengthening health insurance policies and task-improving drug guarantees for seriously ill patients." In Korea, 20 to 30 anticancer drugs and rare diseases are listed on the list of drug benefits every year. Anti-cancer drugs are also expanding their benefit standards for around 20 drugs each year. Claims for serious diseases in 2019 amounted to ₩2.2 trillion, accounting for 11.7% of total drug costs. It has been increasing by 18.5% annually since 2015. Among them, anti-cancer drugs increased by 16% and drugs for rare diseases increased by 28.1%. Professor Ahn said that in order to develop a policy to strengthen guarantee, an evaluation based on the basis of medical non-reimbursement is necessary. It is also necessary to induce reasonable medical use by strengthening the role of medical staff and giving incentives, not by the current HIRA's billing reduction system. Professor Ahn suggests that expanding RSA is the right way to strengthen the guarantee of high-priced drugs. He said, "Unlike other countries, the NHIS receives the drug refund amount under RSA and refunds the patient's compensation as a refund rate, but the upper limit of the health insurance premium is applied." The upper limit is applied differently depending on the income quintile, but it is also worth considering reducing the burden of low-income people and reducing the RSA refund for high-income people, Ahn suggested. He said, "To reduce the burden of high-priced drugs on low-income patients, the drug that has become an RSA on the total amount should also be considered by the NHIS to prepay a certain percentage of drug claims by low-income people as collateral."
- Company
- Korea Pharma has signed a contract to supply Accrufer
- by Aug 27, 2021 05:59am
- Korea Pharma announced on Monday that it has signed an exclusive contract with Shield Theapeutics to supply the anaemic drug Accrufer in Korea. Anemia is very common in patients with inflammatory bowel disease (IBD) and chronic kidney disease (CKD). Poor treatment of anemia increases the morbidity and morbidity of cardiovascular disease. According to Korea Pharma, existing oral anemia treatments have severe side effects such as gastrointestinal disorders and constipation. Since intravenous iron tablets require visiting hospitals once to three times a week, it takes time and is economically burdensome. Accrufer is an ideal alternative because it does not cause side effects such as gastrointestinal disorders and constipation, and absorbs as much iron as the body needs. Accrufer is a formulation that can replace the main used iron in the AEGIS-H2H study published in March 2019. Accrufer is expected to reduce the economic burden of intravenous iron preparations and improve patient conformity. Accrufer is approved by the FDA and EMA and is sold in Europe and the United States. It is the only oral anemia treatment in Korea that has been recognized for its excellent efficacy and safety with FDA approval. "Korea Pharma is a successful pharmaceutical company with outstanding performance in product development and commercial success," CEO Greg Madison said. "Iron deficiency is a global problem, and through this agreement, more iron deficiency patients in Korea will be able to use Accrufer in the near future," he said. Park Eun-hee, CEO of Korea Pharma, expects that the company will be able to provide iron deficiency treatment to Korea through Accrufer. Korea Pharma signed the world's first one-liter PEG bowel cleansing Plenvu exclusive contract with Norgine in December 2018, and this time it has expanded to IBD and CKD through Accrufer exclusive contract.
- Policy
- Clinical trials of Jardiance have been approved
- by Lee, Tak-Sun Aug 26, 2021 05:58am
- The SGLT-2 diabetes treatment has expanded its indication to other treatments for diseases such as heart failure. In Korea, AstraZeneca's Forxiga (Dapagliflozin Propanediol Hydrate) has also been recognized for its efficacy and effect on chronic heart failure and chronic kidney disease. And Boehringer Ingelheim's "Jardiance (Empagliflozin)" is also expanding his indication. EMPACT-MI, which is currently undergoing multinational clinical research, is also a test to seek other treatments for diseases. The MFDS approved the EMPACT-MI (clinical phase 3) for domestic subjects on the 24th. This test is for patients with acute myocardial infarction for hospitalization and death due to heart failure. A test to evaluate the effectiveness of Empagliflozin verifies placebo control superiority. The total number of test subjects for EMPACT-MI is 3,312. Among them, 35 subjects were selected in Korea. The test will be conducted at Busan National University Hospital, Bundang Seoul National University Hospital, Wonju Severance Christian Hospital, Chonnam National University Hospital and Chungbuk National University Hospital. Through the EMPOWER clinical program, Jardiance is seeking treatment in a wide range of areas, including heart, kidney and metabolic diseases. EMPACT-MI is also being carried out as part of EMPOWER. In June, Jardiance was also approved by the EU Commission as a treatment for chronic heart failure in adults with reduced heart rate. However, it was not approved as a treatment other than adult type 2 diabetes in Korea. Compared to competitive drug Forxiga's completion of chronic heart failure and chronic kidney disease, it is slow. Forxiga will also be used in Korea on the 12th for chronic kidney disease. At AstraZeneca's request, the MFDS has decided to add Forxiga's "chronic kidney disease" effect. Forxiga is effective in continuous reduction of estimated glomerular filtration rate (eGFR) in patients with chronic kidney disease, reaching terminal kidney disease, and reducing risk of death and kidney-related death from cardiovascular disease. On December 22 last year, Forxiga acquired chronic heart failure. As a result, it can be used to treat patients with chronic heart failure whose left ventricular contraction function has been reduced by 18 years of age or older. Forxiga's successive addition of indicative symptoms proves the transformation of SGLT-2-based treatments into other treatments other than diabetes. The SGLT-2 series of treatments has a mechanism to control blood sugar by preventing reabsorption of glucose filtered from the kidneys and releasing it. This inhibits the transport "SGLT-2", which simultaneously carries NaCl and glucose. In particular, it is known to have a beneficial effect on heart remodeling and preserve new functions by exhibiting diuretic effects while simultaneously reducing volume overload and reducing blood pressure.
