FDA Begins Review of Alnylam's sNDA for Expanded Amvuttra Use
ALNYAlnylam Pharmaceuticals(ALNY) ZACKS·2024-11-26 23:31

Alnylam Pharmaceuticals (ALNY) announced that the FDA has accepted its supplemental new drug application (sNDA) seeking the label expansion of Amvuttra (vutrisiran) for review to treat ATTR amyloidosis with cardiomyopathy (ATTR-CM). Amvuttra, an RNAi therapeutic, is ALNY’s lead drug, which is currently approved in the United States for treating adult patients with polyneuropathy of transthyretin-mediated (hATTR) amyloidosis. It is also marketed in the EU for treating hATTR amyloidosis in adult patients with ...