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Alnylam Announces Approval in Brazil of ONPATTRO® for the Treatment of Hereditary ATTR Amyloidosis with Polyneuropathy
− ONPATTRO is the First-Ever RNAi Therapeutic Approved in Latin America – CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY),
About this update from Alnylam Pharmaceuticals, Inc.
[{"type":"text","content":"\n− ONPATTRO is the First-Ever RNAi Therapeutic Approved in Latin America –\n\n CAMBRIDGE, Mass.--(BUSINESS WIRE)--\nAlnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, today announced that the Brazilian Health Regulatory Agency (ANVISA) has approved ONPATTRO® (patisiran) for the treatment of hereditary transthyretin-mediated (hATTR) amyloidosis in adults with stage 1 or stage 2 polyneuropathy. hATTR amyloidosis is a rare, progressive condition that is considered endemic in Brazil, affecting more than 5,000 people.i Based on Nobel Prize-winning science, ONPATTRO is the first approved RNAi therapeutic in Latin America and will be the first Alnylam product launched and marketed in the region.\n\n\n“The approval of ONPATTRO in Brazil marks an exciting milestone for so many Brazilians with hATTR amyloidosis in need of a new treatment option that could halt the progression of this debilitating and life-threatening disease. We are grateful to ANVISA for recognizing the significant impact of this disease on patients’ daily lives and for granting approval to the first RNAi therapeutic in Latin America – ONPATTRO – so swiftly, a mere four months after the marketing authorization application was filed. We will continue collaborating with ANVISA and the Ministry of Health in order to incorporate ONPATTRO in the federal program (SUS), to make the drug available to patients in need as soon as possible,” said Norton Oliveira, Senior Vice President, Head of Latin America at Alnylam.\n\n\nONPATTRO’s approval 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\nANVISA granted ONPATTRO priority review, an accelerated review designation awarded to innovative medicines that treat rare diseases. ONPATTRO has previously been approved for use in the U.S., EU, Canada, Japan, and Switzerland. The therapy had been granted Breakthrough Therapy and Orphan Drug designation by the U.S. Food and Drug Administration, along with priority or accelerated review status from regulatory agencies in the U.S., EU, Canada, and Japan.\n\n\nAbout ONPATTRO® (patisiran)\n\n\nONPATTRO is an RNAi therapeutic that was appro...