Biogen and Eisai Complete the Submission of BLA to the US FDA for Aducanumab to Treat Alzheimer’s Disease

Shots:

• The completed submission followed ongoing collaboration with the FDA and includes clinical data from the P-III EMERGE and ENGAGE studies along with the P-Ib PRIME study. Additionally, Biogen has requested Priority Review
• The P-III EMERGE study met its 1EPs in patients treated with a high dose showed a reduction of clinical decline from baseline in CDR-SB scores @78wks. (22%); consistent reduction of clinical decline as measured by- MMSE (18%); ADAS-Cog 13 (27%); ADCS-ADL-MCI (40%); reduction amyloid plaque burden with low/high dose aducanumab @26 & 78wks.
• The P-III ENGAGE did not meet its 1EPs while the P-Ib PRIME study indicated that aducanumab reduced amyloid-beta plaque in a dose/time-dependent fashion with a reduction of clinical decline (CDR-SB & MMSE at 10 mg/kg dose @12mos.) which continued out to 48mos. in the LTE. Additionally, Biogen is working with multiple regulatory authorities to submit BLA including the EU and Japan

Click here to read full press release/ article | Ref: Biogen | Image: Exhibitor Magazine

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