Posted by Michael Wonder on 15 Dec 2021
Alnylam submits regulatory applications to the U.S. FDA and EMA to support label expansion for Oxlumo for the treatment of advanced primary hyperoxaluria type 1
14 December 2021 - Findings from the ILLUMINATE-C Phase 3 study showed substantial reductions in plasma oxalate in PH1 patients with end stage kidney disease, including patients on haemodialysis.
Alnylam Pharmaceuticals announced today the submission of a supplemental new drug application to the U.S. FDA and Type II filing variation to the EMA for lumasiran, an investigational RNAi therapeutic targeting hydroxyacid oxidase 1 – the gene encoding glycolate oxidase – for the reduction of plasma oxalate in the treatment of patients with advanced primary hyperoxaluria type 1.
