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FDA still skeptical of ALS drug ahead of high-stakes meeting


AP Health Writer

WASHINGTON (AP) — The U.S. Food and Drug Administration has posted another negative review of a closely watched drug for the deadly neurodegenerative disease ALS. The FDA review comes ahead of a rare meeting next week where drugmaker Amylyx will have a second opportunity to make a public case for its drug. The drug has become a rallying cause for patients with ALS, their families and members of Congress who’ve joined in pushing the FDA to approve the drug. But regulators said Friday that new analyses submitted by the drugmaker are not “sufficiently independent or persuasive” to establish the drug’s effectiveness. On Wednesday outside FDA advisers will vote on whether to recommend the drug’s approval.

Article Topic Follows: AP National Business

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Associated Press


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