Alnylam Announces Publication of Results from APOLLO-B Phase 3 Study of Patisiran in Patients with the Cardiomyopathy of ATTR Amyloidosis in the New England Journal of Medicine
The FDA on Monday denied approval of Alnylam Pharmaceuticals’ siRNA therapy Onpattro (patisiran) for the treatment of cardiomyopathy of transthyretin-mediated amyloidosis.
Alnylam Stock Trading Halted Today; FDA Advisory Committee to Review Supplemental New Drug Application for Patisiran for the Treatment of the Cardiomyopathy of ATTR Amyloidosis
The FDA’s Cardiovascular and Renal Drugs Advisory Committee will meet tomorrow to discuss the efficacy of Alnylam’s Onpattro (patisiran) for the treatment of cardiomyopathy of wild-type or hereditary transthyretin-mediated amyloidosis (ATTR-CM) in adults.
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, today announced that the U.S. Food and Drug Administration (FDA) has set a date of September 13, 2023 for the meeting of the Cardiovascular and Renal Drugs Advisory Committee to review the supplemental New Drug Application for patisiran, an investigational treatment for the cardiomyopathy of transthyretin-mediated (ATTR) amyloidosis. As previously announced, the FDA has set an action date of October 8, 2023 under the Prescription Drug User Fee Act. An advanced display of the public notice is available in the Federal Register here.
Alnylam Announces U.S. Food and Drug Administration (FDA) Acceptance of Supplemental New Drug Application for ONPATTRO® (patisiran) for the Treatment of the Cardiomyopathy of ATTR Amyloidosis
The FDA has accepted Alnylam’s application for Onpattro in a rare heart disease known as cardiomyopathy of transthyretinamyloidosis (ATTR-CM), a blockbuster territory that Pfizer dominates. But there’s a hitch.
Alnylam Submits Supplemental New Drug Application (sNDA) to U.S. Food and Drug Administration (FDA) for ONPATTRO® (patisiran) for the Treatment of the Cardiomyopathy of ATTR Amyloidosis
Alnylam has offered a closer look at the data that could support Onpattro’s quest to expand into a rare heart disease. While an approval looks likely, some industry watchers have raised fresh doubts about the drug’s commercial opportunity in its potential fight against Pfizer.
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, announced today that the Company will present additional data from the APOLLO-B Phase 3 study of patisiran, an investigational RNAi therapeutic in development for the treatment of transthyretin-mediated (ATTR) amyloidosis with cardiomyopathy, during an oral poster session at the Heart Failure Society of America (HFSA) Annual Scientific Meeting 2022, on September 30, 2022. The Company recently announced positive results from the APOLLO-B study at the 18th International Symposium on Amyloidosis.