Setting aside trouble gaining market access for the newly-approved Aduhelm (aducanumab), Eisai (TYO: 4523) and Biogen (Nasdaq: BIIB) continue to pursue early registration of their next-generation Alzheimer’s med.
Based on discussions with Japan’s Ministry of Health, Labor and Welfare (MHLW), Eisai has been granted permission to use the “prior assessment consultation” process for lecanemab, with the goal of shortening the review period.
The additional data of the application package will now be submitted, with primary endpoint data from the key Clarity AD study expected later in 2022.
This article is accessible to registered users, to continue reading please register for free. A free trial will give you access to exclusive features, interviews, round-ups and commentary from the sharpest minds in the pharmaceutical and biotechnology space for a week. If you are already a registered user please login. If your trial has come to an end, you can subscribe here.
Login to your accountTry before you buy
7 day trial access
Become a subscriber
Or £77 per month
The Pharma Letter is an extremely useful and valuable Life Sciences service that brings together a daily update on performance people and products. It’s part of the key information for keeping me informed
Chairman, Sanofi Aventis UK
Copyright © The Pharma Letter 2024 | Headless Content Management with Blaze