Jul. 27, 2018 • Mamta Mayani .
Alnylam Pharmaceuticals (NASDAQ:ALNY) announces that 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 (EC), the medicine will be commercialized under the brand name ONPATTRO.
The EC will now review the CHMP recommendation to deliver its final decision. Patisiran is currently under priority review as a Breakthrough Therapy, with an action date of August 11. Regulatory filings in other markets, including Japan, are planned for mid-2018. ...