FDA Approves Monthly RNAi Therapy Rivfloza for Primary Hyperoxaluria Type 1

Novo Nordisk announced today that the U.S. FDA has approved its RNAi therapy, Rivfloza (nedosiran) injection (80 mg, 128 mg, or 160 mg), for reducing urine oxalate levels in pediatric patients aged 9 years and older and adults with Type 1 primary hyperoxaluria (PH1) who have relatively preserved kidney function. According to the press release, Rivfloza is the first approved RNAi therapy developed by Novo Nordisk. Primary hyperoxaluria (PH) is an ultra-rare, life-threatening genetic disorder, classified into three known subtypes—PH1, PH2, and PH3—based on genetic mutations.