The US FDA exercised regulatory flexibility on Eisai Co., Ltd. and Biogen, Inc.’s Leqembi (lecanemab-irmb) in its evaluation of clinical efficacy data, and the size of the safety database, for the Alzheimer’s disease drug.
Eisai’s Lecanemab: US FDA Showed Flexibility On Clinical Endpoint Results, Safety Database Size
Alzheimer’s drug’s failure to meet Phase II endpoint did not preclude accelerated approval in light of statistically significant reduction in amyloid plaque and ‘generally consistent and favorable results on clinical endpoints.’ Size of six-month safety database also fell shy of ICH guidelines.
More from Approvals
• By
The Pink Sheet's list of EU centralized approvals of new active substances has been updated to include four new products, one of which is Vimkunya, Bavarian Nordic's chikungunya vaccine.
• By
Levodopa/carbidopa (ND0612), Mitsubishi Tanabe Pharma’s investigational drug-device combination therapy for the treatment of motor fluctuations in people with Parkinson’s disease, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.
• By
Japan recommends eight new drugs for approval, including two for cardiomyopathy, and will also raise prices for multiple products, including Enhertu, on 1 April.
• By
Unofficial January results showed the US FDA continued to issue full and tentative ANDA approvals in line with previous months, but recent layoffs may not help the agency maintain that pace.
More from Product Reviews
• By
Eli Lilly’ will request a re-examination after the European Medicines Agency declined to recommend its Alzheimer’s disease drug Kisunla for EU approval.
• By
The European Medicines Agency’s qualification of the AIM-NASH tool is said to signify a major advancement for clinical trials for metabolic dysfunction-associated steatohepatitis. The market size for MASH treatments is expected to grow substantially in the coming years.
• By
Novartis is planning to file EU and US marketing applications for an intrathecal formulation of its spinal muscular atrophy gene therapy, Zolgensma, in H1 2025.