FDA to Decide on Vutrisiran’s Possible Approval by April 2022

FDA to Decide on Vutrisiran’s Possible Approval by April 2022

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FDA to Decide on Vutrisiran’s Possible Approval by April 2022

Alnylam Pharmaceuticals’ application for the approval of vutrisiran, its investigational therapy for familial amyloid polyneuropathy (FAP), is being reviewed by the U.S. Food and Drug Administration (FDA), with a decision expected by April 14 of next year. The agency has indicated that it is not currently planning to hold an advisory committee meeting as part of the review process. “We are excited that the FDA has accepted our [application] for vutrisiran,” Rena Denoncourt, vice president,…

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