Alnylam Announces Submission Of NDA In Japan For ONPATTRO - Quick Facts

(RTTNews) - Alnylam Pharmaceuticals, Inc. (ALNY) announced it has submitted a New Drug Application (NDA) to Japan's Pharmaceuticals and Medical Devices Agency for approval of patisiran for the treatment of hereditary transthyretin-mediated amyloidosis. The company expects a decision from the MHLW and PMDA in mid-2019.

Patisiran has orphan drug designation from the Ministry of Health, Labor and Welfare, which makes it eligible for priority review as well as 10 years of market exclusivity, if approved. Patisiran is Alnylam's first drug submitted for regulatory review in Japan.