Amvuttra’s label expansion lifts Alnylam toward five-year goals

FDA’s expansion Thursday of Amvuttra’s label to include amyloidosis patients with cardiomyopathy should position Alnylam to satisfy most of the goals of a five-year plan laid out in 2021, CMO Pushkal Garg told BioCentury.

The approval will broaden the market for RNAi therapy Amvuttra vutrisiran, already the top-selling drug from Alnylam Pharmaceuticals Inc. (NASDAQ:ALNY), to include a second category of patients with TTR amyloidosis (ATTR), those with cardiomyopathy — whether hereditary or wild-type. The treatment has been approved since 2022 to treat patients whose hereditary disease presents with polyneuropathy (ATTR-PN)...