FDA Denies Alnylam Pharmaceuticals’ Expansion Plans for Onpattro Treatment

The FDA has denied Alnylam Pharmaceuticals’ request to expand the use of its siRNA injection Onpattro for the treatment of ATTR cardiomyopathy. This decision came despite a 9-3 vote favoring the FDA’s panel of advisors. The rejection will not affect the current availability of Onpattro, which received approval in 2018 for polyneuropathy of hereditary transthyretin-mediated amyloidosis. U.S. expansion plans for patisiran will no longer be pursued, but Alnylam will continue a Phase III study of another ATTR-CM candidate, vutrisiran. The company will now have to wait longer to compete with similar drugs from Pfizer and, potentially, BridgeBio.

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