Date is set for the planned FDA Advisory Committee meeting for Onpattro for the treatment of cardiomyopathy of ATTR amyloidosis
Alnylam, the leading RNAi therapeutics company, announced that the 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. Patisiran is the established name for Onpattro, which is currently approved by the U.S. FDA for the treatment of the polyneuropathy of hereditary ATTR amyloidosis in adults.
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