Posted by Michael Wonder on 31 Jul 2018
Alnylam receives positive CHMP opinion for Onpattro (patisiran) for the treatment of hereditary transthyretin-mediated amyloidosis in adults with Stage 1 or Stage 2 polyneuropathy
27 July 2018 - European Commission decision expected in September.
Alnylam Pharmaceuticals announced today that the CHMP has adopted a positive opinion recommending marketing authorization of patisiran for the treatment of hereditary transthyretin-mediated amyloidosis (hATTR amyloidosis) in adults with stage 1 or stage 2 polyneuropathy. If approved by the European Commission, the medicine will be commercialised under the brand name Onpattro.
The CHMP positive opinion is based on the evaluation of the effects of patisiran in patients with hATTR amyloidosis and its safety profile as demonstrated in the APOLLO Phase 3 study.
