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

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

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

Vartika Singh

Vartika Singh is a content writer who loves to write research articles and reports at PharmaShots. She has in-depth knowledge of the life sciences industry including the Pharma and Biotech sectors. Any articles written by her can be contacted at connect@pharmashots.com.

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