FDA Gives Amylyx’s ALS Drug a Second Chance

July 6, 2022

Amylyx’s application for its ALS drug was narrowly shot down by FDA advisors earlier this year because they were not satisfied with the evidence provided. Fortunately for the biotech, the FDA has agreed to discuss the application again on September 7th.

According to , “But the move to call another hearing for Amylyx’s drug, known as Albrioza in Canada after its conditional approval in the country last month, indicates the FDA is attempting to be as flexible as possible to work with the small biotech. The decision also comes more than a year after the agency was roundly criticized for not calling a second adcomm when discussing Biogen’s controversial Alzheimer’s drug Aduhelm.”

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