ALNY - Alnylam application seeking expanded use of OXLUMO accepted by FDA

The U.S. Food and Drug Administration (FDA) accepted Alnylam Pharmaceuticals (NASDAQ:ALNY) supplemental New Drug Application ((sNDA)) seeking approval of OXLUMO (lumasiran) for reducing plasma oxalate in the treatment of patients with advanced primary hyperoxaluria type 1 (PH1). The FDA is expected to make a decision by Oct. 6. “We are pleased that the FDA has accepted our sNDA for lumasiran 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,” said Pushkal Garg, chief medical officer and EVP, clinical development and medical affairs at Alnylam. In addition the company said that, a Type II Variation for lumasiran to amend the label to further inform on the use of lumasiran in patients with advanced PH1 is under review by European Medicines Agency (EMA). In 2020, OXLUMO was approved by the FDA to

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Alnylam application seeking expanded use of OXLUMO accepted by FDA