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Alnylam : FDA Accepts OXLUMO SNDA For Treatment Of Advanced Primary Hyperoxaluria Type 1

Alnylam Pharmaceuticals Inc. (ALNY) said that the U.S. Food and Drug Administration has accepted the company's supplemental New Drug Application (sNDA) for lumasiran, an investigational RNAi therapeutic targeting hydroxyacid oxidase 1 (HAO1) - the gene encoding glycolate oxidase - for the reduction of plasma oxalate in the treatment of patients with advanced primary hyperoxaluria type 1 (PH1).

The FDA has set an action date of October 6, 2022, under the Prescription Drug User Fee Act (PDUFA).

The company noted that the FDA has accepted the sNDA based on the positive six-month results of the ILLUMINATE-C study showing that lumasiran can substantially reduce plasma oxalate levels in patients with compromised renal function due to PH1, including those on hemodialysis.

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