The US FDA’s Advisory Panel Slams Biogen’s Aducanumab for Alzheimer’s Disease

November 9, 2020 Auto Bot aducanumab, Biogen, P-III, regulatory, reports, Study, Updates, Us FDA 0

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

Click here ­to­ read full press release/ article | Ref: Biogen | Image: The Conversation

The post The US FDA’s Advisory Panel Slams Biogen’s Aducanumab for Alzheimer’s Disease first appeared on PharmaShots.