Alnylam announces filing for marketing authorization of onpattro(patisiran) in brazil for the treatment of hereditary attr amyloidosis with polyneuropathy

Alnylam pharmaceuticals, inc. 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. the 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. onpattro 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 stage 2 polyneuropathy.
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