Alnylam to seek full approval for givosiran for AHP

|About: Alnylam Pharmaceutical... (ALNY)|By:, SA News Editor

Alnylam Pharmaceuticals (NASDAQ:ALNY) announces that it plans to pursue full U.S. approval for RNAi therapeutic givosiran for the treatment of acute hepatic porphyria (AHP). A rolling NDA filing will be initiated this quarter to be completed by mid-2019, contingent on complete data from the Phase 3 ENVISION study.

Previously: Alnylam's givosiran shows positive effect in late-stage AHP study; U.S. marketing application planned; shares ahead 2% premarket (Sept. 27)

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