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

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

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

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


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