Posted by Michael Wonder on 03 Oct 2023
FDA approves Rivfloza for children ≥9 years old and adults living with primary hyperoxaluria type 1, a rare genetic condition
2 October 2023 - Novo Nordisk announced today that the US FDA has approved Rivfloza (nedosiran) injection 80 mg, 128 mg, or 160 mg, a once monthly subcutaneous ribonucleic acid interference therapy, to lower urinary oxalate levels in children 9 years of age and older and adults with primary hyperoxaluria type 1 and relatively preserved kidney function.
This approval is based on the results of the pivotal Phase 2 PHYOXTM2 clinical trial and interim data from the on-going Phase 3 PHYOXTM3 extension study.
