Posted by Michael Wonder on 27 May 2020
Alnylam announces U.S. FDA has granted priority review of the lumasiran new drug application for the treatment of primary hyperoxaluria type 1
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.
