(RTTNews) - Alnylam Pharmaceuticals Inc. (ALNY), a biopharmaceutical company developing RNAi therapeutics, today, announced that the FDA has accepted its supplemental New Drug Application for AMVUTTRA for ATTR amyloidosis with cardiomyopathy (ATTR-CM).
ATTR amyloidosis, caused by a misfolded transthyretin (TTR) protein that accumulates as amyloid deposits in multiple tissues including heart, nerves, and GI tract, is a rare, progressively debilitating, and fatal disease.
AMVUTTRA, whose generic name is Vutrisiran, received FDA approval in June 2022 for the treatment of the polyneuropathy of hereditary transthyretin-mediated (hATTR) amyloidosis in adults.
The FDA decision on the proposed label expansion for AMVUTTRA, i.e., in the proposed ATTR-CM indication, is expected on March 23, 2025, based on the company's use of a Priority Review Voucher.
The supplemental New Drug Application was based on the safety and efficacy data from phase IIII HELIOS-B study in patients with ATTR-CM.
ALNY closed Friday's trading at $244.89, down 0.77%. In premarket trading, Monday, the stock is up 3.38% at $253.16.
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