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Trusted Resources: News & Meetings
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Alnylam Announces FDA Approval of AMVUTTRA™ (Vutrisiran), an RNAi Therapeutic for the Treatment of the Polyneuropathy of Hereditary Transthyretin-Mediated Amyloidosis in Adults
Alnylam Pharmaceuticals, Inc., the leading RNAi therapeutics company, announced that the U.S. Food and Drug Administration (FDA) approved AMVUTTRA™ (vutrisiran), an RNAi therapeutic administered via subcutaneous injection once every three months (quarterly) for the treatment of the polyneuropathy of hereditary transthyretin-mediated (hATTR) amyloidosis in adults. hATTR amyloidosis is a rare, inherited, rapidly progressive, and fatal disease with debilitating polyneuropathy manifestations, for which there are few treatment options. The FDA approval is based on positive 9-month results from the HELIOS-A Phase 3 study, where AMVUTTRA significantly improved the signs and symptoms of polyneuropathy, with more than 50 percent of patients experiencing halting or reversal of their disease manifestations.
The FDA approval of AMVUTTRA is based on positive 9-month results from HELIOS-A, a global, randomized, open-label, multicenter, Phase 3 study that evaluated the efficacy and safety of AMVUTTRA across a diverse group of patients with hATTR amyloidosis with polyneuropathy.
news & meetingsFDA Approves Patisiran Infusion for Hereditary Transthyretin-Mediated AmyloidosisThe FDA announced that it has approved p...
news & meetingsFDA Approves Alnylam’s Onpattro for Polyneuropathy of hATTR AmyloidosisThe FDA today granted Alnylam Pharmaceut...
news & meetingsU.S. FDA Approves VYNDAQEL® and VYNDAMAX™ for Use in Patients with Transthyretin Amyloid Cardiomyopathy, a Rare a...Pfizer Inc. announced today that the U.S...
news & meetingsAlnylam Announces 3-Month Extension of Review Period for New Drug Application for VutrisiranAlnylam Pharmaceuticals, Inc., the leadi...
news & meetingsAlnylam Reports Positive Topline Results From HELIOS-A Phase 3 Study of Vutrisiran in Patients With hATTR Amyloidosi...Alnylam Pharmaceuticals, Inc., the lea...
news & meetingsAlnylam Reports Positive Topline 18-Month Results From HELIOS-A Phase 3 Study of Vutrisiran in Patients With hATTR A...Alnylam Pharmaceuticals, Inc., the leadi...
news & meetingsInotersen: An Exciting Prospect for hATTR Amyloidosis TreatmentA new hereditary ATTR (hATTR) amyloidosi...
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