Novo Nordisk announces FDA approval of Rivfloza injection for PH1

Novo Nordisk announced that the U.S. FDA has approved Rivfloza 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. “The FDA approval of Rivfloza builds on Novo Nordisk’s legacy of advancing research, fostering innovation and creating strategic partnerships to expand treatment options in rare diseases,” said Blandine Lacroix, Senior Vice President, Strategy and Rare Disease at Novo Nordisk Inc. This approval is based on the results of the pivotal phase 2 PHYOX 2 clinical trial and interim data from the ongoing phase 3 PHYOX 3 extension study. PHYOX 2 met its primary endpoint, showing that patients treated with Rivfloza achieved a marked reduction from baseline in 24 hour-urinary oxalate excretion from Day 90 to Day 180.