Alnylam Pharmaceuticals, Inc. 10-Q filed Oct 29, 2026

Modified · Overview

AMVUTTRA is approved in the United States, or U.S., for the treatment of hereditary transthyretin-mediated amyloidosis, or hATTR amyloidosis, with polyneuropathy in adults, in the European Union, or EU, and the United Kingdom, or UK, for the treatment of hATTR amyloidosis in adult patients with stage 1 or stage 2 polyneuropathy, in Japan for the treatment of transthyretin, or TTR, type familial amyloidosis with polyneuropathy, and in multiple additional countries. In March 2025, the United States Food and Drug Administration, or the FDA, approved our supplemental New Drug Application, or sNDA, for AMVUTTRA for the treatment of the cardiomyopathy of wild-type or hereditary transthyretin-mediated amyloidosis in adults to reduce cardiovascular mortality, cardiovascular hospitalizations and urgent heart failure visits. In June 2025, the European Commission, or EC, granted approval of AMVUTTRA AMVUTTRA is also approved for the treatment of wild-type or hereditary transthyretin ATTR amyloidosis in adult patients with cardiomyopathy, following a positive opinion from or ATTR-CM, in the Committee for Medicinal Products for Human Use of major markets in the European Medicines Agency. AMVUTTRA has also been approved by the Brazilian Health Regulatory AgencyEU, or ANVISA, the Japanese Health AuthorityUK, or PMDA, the UK’s Medicines and Healthcare Products Regulatory Agency, or MHRA, and Health Canada for the treatment of ATTR amyloidosis with cardiomyopathyin multiple additional countries. Regulatory reviews continue in other territories.