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

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| Ref: Biogen | Image: Biogen

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