FDA Extends Review Period for Leqembi Alzheimer's Treatment

The U.S. Food and Drug Administration has prolonged its evaluation period for the experimental Alzheimer's treatment, Leqembi, a subcutaneous injection developed through a collaboration between Biogen and Eisai. Originally, a decision from the regulatory body was expected by July of this year, but this timeline has now been adjusted. According to reports from Seeking Alpha, the FDA indicated that more time is necessary to complete a comprehensive review of the application. This extension applies specifically to the supplemental Biologics License Application (sBLA) for Leqembi, a medication designed to be administered as an under-the-skin injection. The original version of Leqembi is already available as an intravenous (IV) infusion, having received accelerated approval from the FDA in January 2023. The companies are now seeking full approval for the IV formulation and a new approval for the more convenient subcutaneous option. Patients currently receive the intravenous Leqembi infusion twice a month. The development of a subcutaneous alternative aims to offer a less burdensome administration method, potentially improving patient access and adherence to treatment regimens. This under-the-skin injection is designed to be given once a week. Biogen and Eisai are actively pursuing a traditional approval pathway for the IV formulation of Leqembi. The FDA is anticipated to make a decision on this application by early next month. Successful approval of both the IV formulation and the new subcutaneous option would broaden the treatment landscape for individuals living with early Alzheimer's disease. This delay in the review process underscores the rigorous scrutiny applied to new drug applications, particularly for complex conditions like Alzheimer's. Both companies are working closely with the FDA to address any outstanding questions and to facilitate the timely completion of the review.