Posted by Michael Wonder on 07 Oct 2022
Alnylam announces FDA approval of supplemental new drug application for Oxlumo (lumasiran) in advanced primary hyperoxaluria type 1
6 October 2022 - Approval is based on positive efficacy and safety results of the ILLUMINATE-C Phase 3 study of Oxlumo in PH1 patients with severe renal impairment, including those on haemodialysis.
Alnylam Pharmaceuticals announced today that the US FDA approved a label expansion for Oxlumo (lumasiran) for the treatment of primary hyperoxaluria type 1 to lower urinary oxalate and plasma oxalate levels in paediatric and adult patients.
