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FDA extends review of Amylyx ALS drug, delaying approval decision

June 3, 2022

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The FDA doesn’t disclose its rationale for extending drug reviews and Amylyx’s statement on the delay offered few details, making it hard to tell how the agency views the company’s application.

Two months ago, expert advisers convened by the FDA recommended the regulator hold off on approving Amylyx’s medicine, having grappled with several issues in how the main study supporting its benefit was run and analyzed. In documents prepared for the meeting, and in presentations to the experts, FDA officials acknowledged the devastating nature of ALS and their promises to be more flexible in reviewing drugs for the condition. But they also questioned how effective AMX0035 really is.

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