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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[Source: Endpoints, October 9th, 2023]