Shots:

• The advisory committee voted 1-8- with 2 members voting uncertain that EMERGE study (without regard for ENGAGE study) provides strong evidence- supporting the effectiveness of aducanumab as a treatment for AD. The committee also voted 0-7 with 4 members voting uncertain that PRIME study provides supporting evidence for aducanumab
• The committee voted 5-0 and 6 uncertain on showing PD effect of aducanumab on AD pathophysiology. Finally- the committee voted 0-10 & 1 for exploratory analyses of Study 301 & 302- along with study 103 and evidence of a PD effect on AD pathophysiology
• Following the committee’s opinion- the US FDA is expected to make a decision on approval of aducanumab’s BLA by Mar 7- 2021

 ­ Ref: Biogen | Image:Biogen