In a twist, Amylyx's ALS drug will get a second crack at adcomm endorsement after FDA decides to reconvene experts
After a close negative vote earlier this year, Amylyx Pharmaceuticals will get another attempt to persuade FDA advisors that its experimental ALS drug is effective.
US regulators will hold a second meeting of the Peripheral and Central Nervous System Drugs Advisory Committee to discuss Amylyx’s application, the biotech announced Tuesday morning. The hearing, which will take place Sept. 7, will come less than six months after the previous meeting ended in a 6-4 vote saying the company did not offer conclusive proof its drug worked.
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