Alnylam gains approval in Brazil for Onpattro

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, RNAi therapy company Alnylam Pharmaceuticals (Nasdaq: ALNY) announced.

hATTR amyloidosis is a rare, progressive condition that is considered endemic in Brazil, affecting more than 5,000 people. 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.

“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.