Alnylam announces U.S. FDA has granted priority review of the lumasiran new drug application for the treatment of primary hyperoxaluria type 1

Alnylam Pharmaceuticals

26 May 2020 - PDUFA date set for 3 December 2020.

Alnylam Pharmaceuticals announced today that the U.S. FDA has accepted the Company’s new drug application for lumasiran, an investigational RNAi therapeutic targeting hydroxyacid oxidase 1 – the gene encoding glycolate oxidase – in development for the treatment of primary hyperoxaluria type 1. 

The FDA also granted priority review for the application, a designation for medicines that have the potential to provide significant improvements in the treatment, prevention or diagnosis of a serious disease, with the goal of FDA taking action within six months compared to 10 months under standard review.

Read Alnylam Pharmaceuticals press release

Michael Wonder

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Michael Wonder