Alnylam gets FDA approval for AMVUTTRA (vutrisiran) for hATTR amyloidosis polyneuropathy

ALNYLAM PHARMACEUTICALS, INC.

FDA approval based on HELIOS-A Phase 3: 17.0-point mean improvement in mNIS+7 vs placebo (p<0.0001); 50% of patients saw improvement.
AMVUTTRA is first FDA-approved treatment for hATTR polyneuropathy with reversal of impairment; subcutaneous injection once every three months.
Launch expected early July; value-based agreements to accelerate patient access.
Under review by EMA, ANVISA, PMDA; HELIOS-B trial for cardiomyopathy ongoing.
Most common adverse reactions: arthralgia (11%), dyspnea (7%), vitamin A decreased (7%).

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