Sanofi, Alnylam Submit MAA To European Medicines Agency For Patisiran

(RTTNews) - Sanofi Genzyme, the specialty care global business unit of Sanofi (SNYNF, SNY), and RNAi therapeutics company Alnylam Pharmaceuticals, Inc. (ALNY) announced Monday the submission of a Marketing Authorization Application or MAA to the European Medicines Agency or EMA for patisiran for the treatment of hereditary ATTR amyloidosis.

Patisiran is an investigational RNAi therapeutic targeting transthyretin or TTR for the treatment of adults with hereditary transthyretin-mediated amyloidosis or hATTR amyloidosis. Patisiran was previously granted accelerated assessment by the EMA, potentially reducing the EMA's evaluation time from 210 to 150 days.

Alnylam announced completion of the submission of a New Drug Application with the FDA on December 12. Sanofi Genzyme is currently preparing regulatory filings for patisiran in Japan, Brazil and other countries, with submissions expected to begin in the first half of 2018.

Pending regulatory approvals, Alnylam will commercialize patisiran in the U.S., Canada and Western Europe, with Sanofi Genzyme commercializing the product in the rest of the world, including certain Central and Eastern European countries of the European Union.

Patisiran has not been approved by the FDA, EMA, or any other regulatory authority and no conclusions can or should be drawn regarding the safety or effectiveness of this investigational therapeutic.