FDA approves Rivfloza for primary hyperoxaluria type 1

The US Food and Drug Administration (FDA) has approved Rivfloza (nedosiran) injection 80mg, 128mg, or 16mg, a once-monthly subcutaneous ribonucleic acid interference (RNAi) therapy, from Danish diabetes care giant Novo Nordisk (NOV: N).

Rivfloza is indicated for the lowering urinary oxalate levels in children 9 years of age and older and adults with primary hyperoxaluria type 1 (PH1) and relatively preserved kidney function.1

This is the second FDA-approved option for the disease after Alnylam’s (Nasdaq: ALNY) rival RNAi therapy Oxlumo (lumasiran) won its FDA approval in November 2020.