Biogen and Eisai Plan to File BLA to the US FDA for Aducanumab to Treat Alzheimer’s Disease

Shots:

• The BLA submission will be based on P-III EMERGE and ENGAGE studies that were discontinued in Mar’2019 following a futility analysis. The new analysis of larger dataset showed that Aducanumab reduced the clinical decline in patients with early Alzheimer’s disease as measured by the pre-specified 1EPs &2EPs
• EMERGE study result: @78wks. reduction of clinical decline as measured by CDR-SB score (23%); high dose showed a consistent reduction of clinical decline as measured by MMSE (15%); ADAS-Cog 13 (27%); ADCS-ADL-MCI (40%); patients from ENGAGE study achieved sufficient exposure to high dose aducanumab supported the findings of EMERGE
• Aducanumab is an investigational mAb targeting amyloid-beta with its anticipated BLA submission to the US FDA in H1’2020. Biogen will continue in talks with regulatory authorities in EU & Japan and will submit BLA based on P-I/Ib studies as well P-III EMERGE and ENGAGE studies

Click here to­ read full press release/ article | Ref: GlobeNewswire | Image: Drug Delivery Business