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Alnylam Announces Filing for Marketing Authorization of ONPATTRO® (patisiran) in Brazil for the Treatment of Hereditary ATTR Amyloidosis with Polyneuropathy
– Filing Marks the First RNAi Therapeutic to be Submitted for Potential Approval in Latin America – – Submission Made Under the Accelerated Regulatory
About this update from Alnylam Pharmaceuticals, Inc.
[{"type":"text","content":"\n– Filing Marks the First RNAi Therapeutic to be Submitted for Potential Approval in Latin America –\n\n\n– Submission Made Under the Accelerated Regulatory Pathway for Rare Diseases –\n\n CAMBRIDGE, Mass.--(BUSINESS WIRE)--\nAlnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, today announced that the marketing authorization application of patisiran for the treatment of patients with hereditary transthyretin-mediated (hATTR) amyloidosis with polyneuropathy has been filed with the Brazilian Health Regulatory Agency (ANVISA). Patisiran has been granted priority review by ANVISA which is awarded to innovative medicines that treat rare diseases under this accelerated regulatory pathway. Alnylam expects a decision from ANVISA in the first half of 2020.\n\n\nPatisiran – which will be commercialized following regulatory approval under the brand name ONPATTRO® – is Alnylam’s first investigational drug submitted for review in Brazil. If approved, it will be the first product to be launched and marketed by Alnylam in the country and the first ever RNAi therapeutic to be approved in Latin America.\n\n\n“The filing of our registration submission for patisiran in Brazil is an important step forward in our continued commitment to bring RNAi therapeutics to people around the world,” said Norton Oliveira, Senior Vice President, Head of Latin America at Alnylam. “hATTR amyloidosis is a rare progressive condition that is considered endemic in Brazil, affecting more than 5,000 people. Symptoms can manifest throughout the entire body and have a devastating impact on patients. We look forward to working closely with ANVISA to bring patisiran to these patients in need as quickly as possible.”\n\n\nThe registration submission is based on positive data from the APOLLO Phase 3 study, which evaluated the efficacy and safety of patisiran in hATTR amyloidosis patients with polyneuropathy. Results from the APOLLO study were published in the July 5, 2018 issue of The New England Journal of Medicine.\n\n\nONPATTRO is approved by the U.S. Food and Drug Administration (FDA) for the treatment of the polyneuropathy of hATTR amyloidosis in adults. ONPATTRO is also approved for this indication in Canada and Japan, and is approved in the European Union and Switzerland for the treatment of hATTR amyloidosis in adults with Stage 1 or ...