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Will Amylyx’s ALS Drug Benefit From US FDA’s Aduhelm Experience?

 
• By Derrick Gingery

A rare second advisory committee meeting is scheduled for Amylyx’s ALS drug to discuss additional analyses that the company submitted, allowing another glimpse into the FDA’s pre-decision thinking.

Astrocyte and blood vessel
The second advisory committee meeting will offer another opportunity for the public to learn about FDA's thinking on AMX0035. • Source: Shutterstock

A second advisory committee meeting to consider additional information about Amylyx Pharmaceuticals, Inc.’s amyotrophic lateral sclerosis (ALS) drug AMX0035 may be an attempt by the US Food and Drug Administration to keep the public updated about new application information, and could be a sign that the agency is adapting its approach in the wake of criticism of how it handled the approval of Aduhelm.

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