Alnylam announces FDA advisory committee meeting for ONPATTRO in ATTR cardiomyopathy on Sept 13, 2023

ALNYLAM PHARMACEUTICALS, INC.

FDA Advisory Committee (Cardiovascular and Renal Drugs) to review sNDA for patisiran in cardiomyopathy of ATTR amyloidosis on Sept 13, 2023.
PDUFA action date set for October 8, 2023.
ONPATTRO currently approved for polyneuropathy of hATTR amyloidosis; sNDA aims to expand label to cardiomyopathy.
Safety and efficacy for cardiomyopathy indication have not yet been established by FDA.

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