ALNY - Alnylam submits sNDA to expand label of Oxlumo in rare kidney disorder

Alnylam Pharmaceuticals (NASDAQ:ALNY) has submitted a sNDA to the FDA for a label expansion of Oxlumo to include reducing plasma oxalate in advanced primary hyperoxaluria type 1 (PH1). A Type II Filing Variation for Oxlumo (lumasiran) was also submitted European Medicines Agency . The applications are supported by results from the phase 3 ILLUMINATE-C trial which showed significant declines in plasma oxalate in PH1 Patients with end-stage kidney disease. Oxlumo targets hydroxyacid oxidase 1, the gene encoding glycolate oxidase. Read more about late-stage data of Oxlumo in PH1.

For further details see:

Alnylam submits sNDA to expand label of Oxlumo in rare kidney disorder