The accelerated approval Biogen, Inc. and Eisai Co., Ltd.’s amyloid-targeting antibody Aduhelm (aducanumab-avwa) for Alzheimer’s disease was a seminal moment in the development of the companies’ Leqembi (lecanemab-irmb) for the same population.
Leqembi Clinical Development: Aduhelm Opened The Door For Accelerated Approval
Timeline of lecanemab’s clinical development shows how, almost three years after telling Eisai and Biogen that their Phase II results did not support regular or accelerated approval, the FDA review division reversed course following its decision to approve aducanumab on a surrogate endpoint.
More from Drug Review Profiles
• By
The Pink Sheet drug review profile investigates the long and rigorous process behind the FDA’s recent relaxation of the cardiovascular safety warning for testosterone products.
• By
The Pink Sheet Drug Review Profile breaks down the FDA's long reckoning with testosterone cardiovascular safety concerns
• By
Vadadustat's review overlapped with two other oral HIF-PH class drugs. Safety issues with FibroGen/AstraZeneca’s roxadustat drew attention during vadadustat's first-cycle review, while GSK’s Jesduvroq labeling and postmarketing requirements informed the second-cycle approval.
• By
The Pink Sheet Drug Review Profile explores the US FDA’s approval of vadadustat to treat anemia in chronic kidney disease patients on dialysis. A complete response letter cited the risk of drug-induced liver injury, but postmarketing data from Japan reassured reviewers.
More from Product Reviews
• 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.
• By
Sponsors of three drugs that are in the final stages of the EU regulatory review cycle are due to make the case for marketing approval before the European Medicines Agency.
• By
The European Medicines Agency is this week set to issue an opinion on whether pan-EU marketing should be granted to Lilly’s Alzheimer’s disease drug donanemab.