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- 2026-04-13 10:24:09
- Company
- Keytruda's sales have been leading for two consecutive years
- by Chon, Seung-Hyun Nov 26, 2021 05:54am
- Keytruda, an immuno-cancer drug, has been leading the domestic pharmaceutical market for the second consecutive year. K-CAB continued to soar among new drugs from multinational pharmaceutical companies. According to IQVIA, a pharmaceutical research institute on the 26th, Keytruda of MSD Korea recorded 145.5 billion won in sales in the third quarter of this year, the largest number of all medicines. It recorded a high growth rate of 27.8% year-on-year, widening the gap with the second-ranked Lipitor by more than 30 billion won. Until the first half of the year, the gap between Keytruda and Lipitor was 19.9 billion won. Keytruda ranked first among all medicines for the first time with sales of 155.7 billion won last year. Keytruda, released in Korea in 2015, is an immune checkpoint inhibitor that treats cancer through activation of immune cells by inhibiting "PD-1" protein on the surface of immune cells T cells to prevent binding with PD-L1 receptors. In Korea, 18 indications were approved for 14 carcinomas, including melanoma, lung cancer, and head and neck cancer. Keytruda's quarterly sales remained around 3 billion won immediately after its release, but sales began to rise rapidly since August 2017 when insurance benefits were applied as a secondary treatment for non-small cell lung cancer. Keytruda surpassed 50 billion won in sales in the third quarter. If this trend continues, sales are expected to surpass 200 billion won this year. Keytruda also posted cumulative sales of $12.6 billion in the third quarter of this year in the global market. Perjeta and Prolia, new drugs from multinational pharmaceutical companies, also showed high sales growth. Roche's Perjeta recorded 69.1 billion won in cumulative sales in the third quarter, up 29.9% from the previous year. Perjeta is a drug administered in combination with Docetaxel and Trastuzumab in metastatic or localized HER2 positive breast cancer patients who are not operable and have never received HER2 targeted anticancer drugs or chemotherapy. Amgen's Prolia's cumulative sales in the third quarter amounted to 65.2 billion won, up 18.7% from the same period last year. Prolia, released in Korea in November 2016, is a biopharmaceutical osteoporosis treatment targeting protein RANKL. Since 2017, sales of Prolia have started to rise since salaries were applied only to secondary treatment therapy. Since April 2019, sales of Prolia have increased rapidly as insurance benefits have been recognized for primary treatment therapy. Chong Kun Dang is jointly selling Prolia with Amgen. It is an interesting phenomenon that Sanofi's antithrombotic drug Plavix increased 18.6% year-on-year to 46.8 billion won in cumulative sales in the third quarter. Plavix's patent expired in 2007, and more than 100 generics have entered. More than 10 years have passed since the patent expired, and sales have rather increased despite competing with more than 100 generics.
- Policy
- Winner of pricing suits will be compensated for damages
- by Kim, Jung-Ju Nov 26, 2021 05:54am
- The countless litigations between government and companies regarding reimbursements such as drug price cuts or reduced scope of reimbursement are causing wasteful losses to both parties. On this, the government and the National Assembly have been proposing various solutions to prevent excessive stay of executions. The NA has proposed an amendment to the National Health Insurance Act which allows government authorities to recover the reflective profits the companies accrued during the suspension of execution period if it wins the main lawsuit, and refund them to companies when vice versa after a pharmaceutical company applies for administrative litigation and suspension of execution in opposition to the disposition of drug price cuts. The bill passed the plenary session after passing the Health and Welfare Committee's bill review subcommittee. The biggest contributor to the implementation of this refund system was the stay of execution the companies filed with their drug pricing lawsuits. The stay of execution is filed by a pharmaceutical company to suspend execution of the government’s drug price cut disposition based on the presumption of innocence. In general, the court cites or accepts the stay of execution request because of ‘irrecoverable damages’ that may occur from the company’s aspect. Since 2018, 36 out of 38 stays of executions were accepted, with the other two suits withdrawn. Most of the litigations have resulted in favor of the government. The problem is that the company’s only option during the suit to defend its drug price is to use the stay of execution and minimize damage or maximize profits during the litigation period. In this case, any cost that arises from the non-change in the drug price during the trial period results in a loss in health insurance finances. The government estimates that the financial loss caused by the suspension of drug price cuts since 2018 amounts to nearly ₩400 billion. Broadly applied to price cuts, reimbursement suspensions, selective reimbursement, etc. Will include added interest… price-cut drugs may choose either a lump-sum payment or price raise The refund system will be used to reduce such side effects. The system will be applied when a stay of execution filed by the pharmaceutical company is dismissed at the administrative ruling or litigation, but accepted in the original suit. In other words, the system will be applied when the government loses and the pharmaceutical company wins the suit. The compensation for damages will be applied to all pharmaceutical dispositions that are directly related to pharmaceutical sales, such as pricing adjustments, reimbursement suspensions or exclusions, reduced scope of reimbursement, selective reimbursement (changed copayment rate), etc. If these requirements are met, the NHIS needs to pay the pharmaceutical companies for the losses as a “binding act,” meaning that the government must compensate for losses. The government has decided to announce the standard rules and amendments to the medical insurance benefit criteria next month. Considering the administrative procedures such as legislative notice, regulatory review, legislative review, and public announcement, the amendment is expected to be implemented within the first half of next year.
- Company
- Will the sale of impurity Losartan be okay?
- by Kim, Jin-Gu Nov 26, 2021 05:53am
- It is focusing on announcing the results of the MFDS. Anxiety in production and sales sites surrounding Losartan impurities is rising. As self-inspection results begin to come out for each manufacturer, consignment companies that received these results are agonizing over whether to preemptively suspend sales or continue sales. According to the pharmaceutical industry on the 24th, Arlico Pharmaceutical, Aju, and CTC Bio decided to stop selling Losartan-containing products. In the case of Arlico, the company decided to voluntarily withdraw along with the suspension of sales. At least five companies are confirmed to have officially decided to suspend sales about a week after concerns over Losartan impurities arose in earnest on the 16th. In addition to the three companies that decided to suspend sales on the 24th, Hutecs Pharmaceutical has begun to suspend sales. Mothers Pharmaceutical has not stopped selling Losartan, but has temporarily suspended the supply to new customers. On top of that, it is confirmed that many companies have unofficially suspended sales and supply. It is predicted that the number of companies suspended from sales is likely to increase further in the future. An official from the pharmaceutical industry said, "We have virtually stopped supplying it. "We don't know what measures the MFDS will take later, but it's to reduce the burden of voluntary recovery just in case," he said. Another company official said, "We have not yet received results from the consignee. However, if there is a problem, we plan to preemptively suspend sales", he explained. On the contrary, some pharmaceutical companies say they will continue to sell and supply until the MFDS announces. In this regard, a company official said, "There are many requests from suppliers. Since it has become difficult to obtain the product as several companies have stopped selling on their own, we will continue to supply it for now, even if we recover it later."
- Policy
- Cost bearer in debate ahead recall of some losartan products
- by Lee, Tak-Sun Nov 26, 2021 05:53am
- The MFDS has mentioned ‘re-prescribing or re-dispensing' some items at meetings with medical, pharmacist, and pharmaceutical associations while discussing measures to recall some of the antihypertensive ‘losartan’ products that were found to contain azido impurities during inspections. The re-prescribing or re-dispensing measures are prepared for cases when patients cannot exchange their drugs at pharmacies, and all lot numbers of some losartan items are highly likely to be recalled. In other words, some items will be subject to full recalls. Previously, the valsartan and ranitidine products that were fully recalled due to impurities had also been re-prescribed or re-dispensed. At the time, the patients’ out-of-pocket cost was borne by medical care institutions for valsartan, and by the National Health Insurance Service for ranitidine. The NHIS had later filed a suit to claim the re-prescribing and re-dispensing cost borne to the pharmaceutical companies. However, as medical and pharmaceutical associations believe the patients’ out-of-pocket cost should be borne by pharmaceutical companies, the issue is expected to raise much controversy this time. According to the industry on the 25th, the MFDS had held a series of meetings with doctors, pharmacists, and pharmaceutical associations on the 24th. At the meetings, the MFDS had mentioned the possibility of re-prescribing and re-dispensing some losartan items, upon which the associations expressed the position that pharmaceutical companies should bear the patients’ out-of-pocket costs that arises from prescribing and re-dispensing while minimizing product recalls. In summary, it seems that full recall of some losartan items will be inevitable. If re-prescribing or re-dispensing measures take place, conflict may arise over who pays for the patients’ out-of-pocket cost and NHIS cost. The government, as well as the medical and pharmaceutical groups, believe that pharmaceutical companies should bear the cost, whereas the pharmaceutical industry is reluctant to bear the cost as this is an unintentional impurity event. However, the analysis is that the companies may accept bearing the out-of-pocket cost of patients. If only a few products are subject to exchange or re-prescriptions, there is the possibility that the recall will proceed without much confusion like in the case of the last AZBT losartan recalls. Therefore, the attention is focused on how many items will be recalled, and what proportion of the products will be re-prescribed at the official announcement made by the MFDS. The MFDS announcement is highly likely to come in early December after the MFDS receives and aggregates pharmaceutical companies’ product impurity test results at the end of this month. The MFDS also plans to hold a meeting soon with pharmaceutical companies that possess products subject to recalls.
- Policy
- All agreed to the legislation of the CSO reporting system
- by Lee, Jeong-Hwan Nov 26, 2021 05:53am
- The MOHW, as well as KPBMA, KRPIA, and Korean Pharmaceutical Association, approved the mandatory government and local government reporting bill by CSO. Except for the opinion that the regulations related to the CSO reporting system should be tightened compared to the legislation pending in the National Assembly, no organizations opposed it. Depending on the results of this month's subcommittee's review, the legislation is expected to be completed within this year and implemented as early as early as next year due to the government's fear. This is the result of confirming the review data of the National Assembly's Health and Welfare Committee's bill 1 subcommittee on the revision of the Pharmaceutical Affairs Act and Medical Device Act on the introduction of the CSO reporting system for medicines and medical devices on the 23rd. The bill, proposed by Rep. Kim Sung-joo of the Democratic Party of Korea, requires CSOs to report to the heads of cities, counties, and districts as prescribed by Ordinance of the MOHW. Pharmaceutical companies, which are pharmaceutical suppliers, can entrust drug promotion work only to CSOs who have been reported. Consignment of drug promotion work to unreported CSOs was sentenced to up to three years in prison or fined up to 30 million won, and CSOs were prohibited from re-consigning drug promotion work. Violation of this will result in imprisonment for up to three years or a fine of up to 30 million won. In addition, CSO representatives, executives, and workers were obligated to complete the drug sales order training. Violations will be fined up to 1 million won. All KPBMA, KRPIA, and Korean Pharmaceutical Association agreed Both organizations representing the domestic and foreign pharmaceutical industries and pharmacist organizations, including the government, approved the bill. Rather, it submitted an opinion to further specify the CSO reporting method or raise the level of regulation. The MOHW predicted that the CSO reporting system will clarify those subject to CSO for medicines and medical devices and incorporate them into the legal system so that administrative authorities can manage and supervise them. The MOHW agrees with Rep. Kim Sung-joo's proposal to eventually strengthen the management of the distribution order of medicines and medical devices by blocking indirect illegal rebates through CSO by establishing the obligation to prohibit rebates. KPBMA also approved the bill. However, it urged pharmaceutical companies to clarify the purpose of the law by adding content that imposes management obligations for CSOs. KRPIA demanded stricter regulations against the bill, asking pharmaceutical companies to specify legal grounds for CSO to request information such as whether to report under the Pharmaceutical Affairs Act and whether representatives, executives, and employees complete rebate prohibition training. The Korean Pharmaceutical Association also said the bill could contribute to preventing illegal rebates by identifying the current status of CSO and ensuring transparent distribution networks. The Korean Pharmaceutical Association further proposed the introduction of a punitive fine in consideration of the reality that it is difficult to eradicate illegal rebates. Only the provisions for re-consignment of CSO in the validity of the bill are changed. Hong Hyung-sun, an expert at the National Assembly's welfare committee, also agreed with the purpose of the bill to make the distribution order of medicines and medical devices correct. It did not prohibit re-consignment between CSOs, but expressed an opinion on changing the provisions so that the consignment route could be identified. In order for the CSO to re-consign drug promotion work to another CSO, it is to stipulate that the original drug provider is informed of the facts as prescribed by the MOHW. In addition, pharmaceutical companies and CSOs presented revised opinions on the contents of the promotion work consignment and the clause requiring the other party to prepare a "consignment report" within one month from the contract date and keep it for five years with evidence. Violation of this would result in imprisonment for up to one year or a fine of up to KRW 10 million, and the CSO definition would include cases where drug promotion work was re-consigned. In addition to preparing grounds for cancellation of designation by CSO educational institutions, Hong also proposed an incidental amendment to establish a hearing procedure in case of cancellation of designation.
- Company
- Tabrecta and Tepmetko are approved simultaneously for NSCLC
- by Nov 25, 2021 05:56am
- Two new anticancer drugs that target the MET gene to treat non-small cell lung cancer have entered the Korean market. The two drugs are Novartis’ ‘Tabrecta (capmatinib)’ and Merck’s ‘Tepmetko (tepotinib)’ The Ministry of Food and Drug Safety approved Tabrecta and Tepmetko together on the 23rd. Both are targeted therapies that target MET mutations and have the same indications. Tabrecta and Tepmetko may both be used to treat locally advanced or metastatic NSCLC harboring MET exon 14 skipping mutations. Various mutations that induce cancer cell growth occur in NSCLC. Dysregulation in the proto-oncogene MET that is located in the long arm of chromosome 7 is also one of such many mutations. MET dysregulation can largely be divided into MET amplification or MET mutation. The MET exon 14 skipping mutation that is targeted by Tabrecta is one of the most commonly reported oncogenic MET mutations. MET exon 14 skipping mutation overstimulates the MET pathway that plays a key role in the signaling, proliferation, and survival of cells, resulting in the proliferation of cancer cells. MET exon 14 skipping (METex14) alterations are rare, occurring in only around 3% of all patients with metastatic NSCLC. However, its prognosis is poor due to its aggressive nature. In particular, retrospective analysis on patients with MET exon 14 skipping mutations showed that 37% of the patients had brain metastasis and 49% had bone metastasis at diagnosis. Tabrecta and Tepmetko are drugs that selectively inhibit the MET receptor tyrosine kinase. It blocks the MET phosphorylation response by binding to the intracellular kinase domain. In the US, Novartis’ Tabrecta was first approved and listed as the first MET targeted anticancer therapy. Tabrecta was approved in May last year, and Tepmetko in February of this year by the US FDA. In Korea, both were authorized simultaneously and are on an equal footing. At the pivotal GEOMETRY mono-1 trial, Tabrecta demonstrated a 68% objective response rate (ORR) and 41% ORR in treatment-naïve and previously treated patients, respectively. The duration of response (DoR) was 12.6 months and 9.7 months, respectively. Tepmetko demonstrated a 43% ORR in patients regardless of treatment experience, and DoR was 10.8 months ORR in treatment-naïve patients and 11.1 months in previously treated patients Both companies are also actively studying the combined use of their respective drugs with EGFR-targeted therapies with the hope that it could address the issue of resistance that patients acquire after treatment with EGFR inhibitors. MET mutation or amplification are key mutations that cause EGFR-TKI resistance. In this context, the companies are studying the combination of Tabrecta with Iressa, Tagrisso, etc, and Tepmetko with Tagrisso.
- Company
- Shionogi's stock price is soaring
- by Eo, Yun-Ho Nov 25, 2021 05:56am
- Shares of Japan's Shionogi Pharmaceutical, which is developing a treatment for COVID-19 with Ildong Pharmaceutical, are on the rise day after day. According to related industries, Shionogi's stock price has steadily risen since August, breaking this year's highest price. As of the 24th, Shionogi Pharmaceutical's stock price is trading at around 8,100 yen, up nearly 40% from 5,950 yen on July 27, when it announced the launch of phase 1 clinical trial for COVID-19. This is analyzed due to expectations for the oral COVID-19 treatment S-217622, which is being developed by Shionogi. In particular, in the case of the 17th, it has been on the rise since the announcement that domestic pharmaceutical company Ildong Pharmaceutical has started joint development of S-217622. On the 17th, Ildong Pharmaceutical announced in a media report that it received IND approval from the Ministry of Food and Drug Safety for phase 2/3 clinical trials of S-217622 and that it would immediately begin clinical trials. S-217622 clinical trials will be conducted simultaneously in Japan, Korea, and Singapore, and its strategy is to shorten the development period and secure sufficient data through multinational clinical and joint development to prove the value of drugs. According to previous studies, S-217622 showed excellent safety and drug resistance, and it prevents virus proliferation by inhibiting protease (3CL-protase) present only in SARS-CoV-2, the source of infection that causes COVID-19. It was confirmed that alpha, beta, gamma, and delta corona-19 mutations all have similar levels of viral proliferation inhibition capabilities. Above all, the convenience of taking oral medicine once a day is drawing attention as a strength over the selective treatment. Meanwhile, if commercialization of S-217622 is successful, Ildong Pharmaceutical is expected to promote its own production and distribution.
- Product
- Organon aims to resume Cozaar XQ supply from 2022 Q1
- by Nov 25, 2021 05:56am
- 'Cozaar XQ,' an antihypertensive combination drug that contains losartan, may be resupplied to pharmacies within the first quarter of next year, at the earliest. The company had made preparations to change the API source of Cozaar XQ to be the same as the one for Cozaar, which uses a losartan API from a different overseas manufacturer (France), and explained that it will start manufacturing in December next month to supply the market in the first quarter of 2022. The company had stopped the shipment of Cozaar XQ after impurities that exceed the standard level were detected in the API of Cozaar XQ during the company’s independent inspections. Currently, the supply of Cozaar XQ 5/50mg, 5/100mg, 10/50mg has been temporarily suspended. Organon recently announced through medical and pharmaceutical associations that “Cozaar tab., Cozaar 100mg tab., Cozaar Plus tab, Cozaar Plus Pro tab, and Cozaar Plus F tab are imported after being manufactured using a losartan API from an overseas manufacturer. After an internal review that included an assessment of the overseas manufacturer’s API manufacturing process, impurity impact, and the European regulatory agency's laboratory results, we have submitted the review results to the MFDS. Also, we are in the process of developing a testing method according to MFDS instructions." Also, the company explained that it is preparing to change the API manufacturing source of Cozaar XQ to be the same as for its Cozaar products and plans to start supply in the first quarter of next year. Organon said, “We will actively follow MFDS instructions to enable the smooth supply of our products without inconveniencing the patients and HCPs.” Meanwhile, prescriptions of Cozaar XQ had recorded 7.2 billion won.
- Policy
- Losartan, which has a high proportion of consignment
- by Lee, Tak-Sun Nov 25, 2021 05:55am
- Concerns are growing as the proportion of consignment production is high in HBP treatment "Losartan" formulation, which is known to have excess Azido-based impurities. If it appears as an impurity problem at the raw material stage, there is a possibility that many pharmaceutical companies tied up with consignment will start collecting products. According to the Ministry of Food and Drug Safety on the 22nd, in the case ofLosartan 50mg, 16 companies in Korea manufacture it, but the number of licensed products is 88. 72 pharmaceutical companies are entrusting manufacturing to other companies. The factory that manufactures the most items is Withus Pharmaceutical's Anseong Plant 1, which produces a total of 21 items, and Youngil Pharmaceutical's Jincheon Plant 1 is followed by 18 items. Withus Pharmaceutical Anseong Plant 1 and Youngil Pharmaceutical's Jincheon Plant 1 also manufacture the largest number of items in combination of HCTZ+Losartan potassium (12.5 mg/50 mg) . Withus Pharmaceutical Anseong Plant 1 produces 15 items, and Youngil Pharmaceutical Jincheon Plant 1 produces 20 items. If there is a problem with the consignment factory product, it is highly likely that the consignment item will be the same problem. In particular, if the same raw material is used, there is a high risk of recovery at the same time. In the industry, this interpretation is possible as companies have recently temporarily suspended product shipments due to raw material problems. Withus Pharmaceutical, which produces the most items of Losartan potasium 50mg, has decided to voluntarily recover its Withus 50mg (2 lots) as of the 16th. Dasan Pharmaceutical's "New Cosar 50mg" (2 lots) produced in the same factory also decided to voluntarily recover as of the 15th. Currently, only two recovered items announced by the Ministry of Food and Drug Safety as Azido-based impurities are Withers Pharmaceutical and Dasan Pharmaceutical, but it is analyzed that there is a possibility of further increase in the future. In fact, the industry believes that more items have stopped selling or voluntarily took measures to recover them. Analysts say that if the Ministry of Food and Drug Safety collects the results of the investigation and turns out to be a raw material problem, it is likely to lead to a large-scale recovery.
- Product
- α-GPC can't be replaced with other drugs in the field
- by Kim, Jin-Gu Nov 25, 2021 05:55am
- Apart from the steady increase in the number of patients over the past 20 years, there has been no significant change in dementia treatments used in Clinic sites. However, two major changes have been predicted in the past two years. One is the controversy over the preparation of Choline alfoscerate in Korea, and the other is the controversy surrounding Aducanumab, a new dementia treatment drug that has been released for more than 20 years. The controversy is whether the drug is effective enough. The solution to the controversy is quite similar. Regulators in South Korea and the U.S. have instructed the controversy surrounding the two drugs to properly verify their validity through "clinical re-evaluation." What do the front-line prescription sites think about these controversies? Regarding the controversy over Choline alfoscerate, Ha Sang-wook, head of On Hospital, said, "It seems to help clinically improve cognitive function in early dementia," adding, "There will be positive results that re-verify the effectiveness of clinical re-evaluation." ◆ The prescription amount is similar to the previous one in reducing the benefit of Choline alfoscerate The core of the controversy is the effectiveness of Choline alfoscerate. This is because drugs were recognized as medicines in Italy, where drugs were developed, while in other countries they were sometimes used as health functional foods. In the end, the Ministry of Food and Drug Safety ordered a "clinical re-evaluation" last year to re-evaluate the safety and effectiveness of Choline alfoscerate on its own. 57 companies, including Daewoong Bio and Chong Kun Dang, have begun clinical re-evaluation. The Ministry of Health and Welfare has reduced the benefit of the Choline alfoscerate. Since August last year, when patients who have not been diagnosed with dementia use Choline alfoscerate, the drug price rate has risen from 30% to 80%. Pharmaceutical companies have actively taken legal action. Currently, a lawsuit for revocation of administrative disposition is underway. Regarding the controversy over the effectiveness of Choline alfoscerate, manager Ha Sang-wook explained, "There are many studies that improve cognitive function when dementia or dementia drugs are not activated in the early stages." He said, "Clinically, when replaced with Choline alfoscerate from other drugs, it is observed that it leads to cognitive improvement." For this reason, he explained that despite the reduced benefit, the prescription amount is almost the same as before. Manager Ha Sang-wook said, "First of all, it is a drug that patients are very satisfied with. Even if the prescription is changed to another drug, it is often prescribed again as Choline alfoscerate, he said. "I understand that it is prescribed steadily not only in our hospital but also in other places." He said there was no suitable drug to replace Choline alfoscerate. He said, "Except for Choline alfoscerate, there is virtually no drug to prescribe to patients." He said, "In particular, in the case of vascular dementia, Donepezil is not applied, so it cannot be used. Choline alfoscerate is the drug to be used, and if this drug is not allowed to be used, it is quite difficult for patients and doctors to use it, he said. He was also optimistic about the results of clinical re-evaluation. Manager Ha Sang-wook explained, "The key will be how many patients with hidden cognitive impairment are discovered." He said, "I think more patients with cognitive impairment will get good enough results if they participate in clinical trials. The Dementia Association is also formed in a positive direction". ◆"Patients' interest in Aducanumab is increasing rapidly Expectations were high for the new dementia treatment "Aducanumab" recently approved in the United States. In June this year, the U.S. Food and Drug Administration (FDA) approved Aducanumab, co-developed by Biogen and Eisai, as a treatment for Alzheimer's dementia. It has been about 20 years since Allergan's Namenda in 2003. However, controversy over the validity of this drug has continued since the approval process. Conflicting results were found in two clinical trials conducted by Biogen. For this reason, the FDA Advisory Committee issued a non-approval recommendation in November last year. The FDA did not accept the advisory committee's opinion. However, in consideration of the controversy over its validity, the condition of "reevaluation after clinical trials" was attached. Biogen should reevaluate Aducanumab through post-marketing clinical trials. If the efficacy of Aducanumab is not proven in the re-evaluation, the approval will be revoked. In terms of controversy alone, it is almost similar to the case of Choline alfoscerate in Korea. Many patients ask a lot about this drug, he said. "The success of Aducanumab will significantly change the direction of dementia treatment itself. If proven effective, dementia will turn into a conquerable disease. On the contrary, if clinical trials fail, follow-up drugs of the same mechanism are likely to fail, he said. Since the approval of Aducanumab, several pharmaceutical companies have been developing drugs with beta-amyloid blocking mechanisms. In June this year, Eli Lilly's "Donanemab" and "Lecanemab," co-developed by Eisai and Biogen, were designated by the FDA for breakthrough therapy designation one after another. Both drugs are undergoing phase 3 global clinical trials.
