Alnylam announces U.S. FDA granted priority review of the givosiran new drug application for the treatment of acute hepatic porphyria

Alnylam Pharmaceuticals

5 August 2019 - PDUFA date set for 4 February 2020.

Alnylam Pharmaceuticals announced today that the U.S. FDA has accepted the Company’s new drug application for givosiran, an investigational RNAi therapeutic targeting aminolevulinic acid synthase 1 in development for the treatment of acute hepatic porphyria, and granted Priority Review for the application.

Givosiran also previously received breakthrough therapy designation from the FDA and orphan drug designation in the U.S., as well as Priority Medicines (PRIME) designation from the EMA and orphan drug designation in the EU.

Read Alnylam Pharmaceuticals press release

Michael Wonder

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Michael Wonder