Novo Nordisk gets USFDA nod for Rivfloza injection for rare genetic condition
Rivfloza, the RNAi therapeutic by Novo Nordisk, was developed using the proprietary GalXC RNAi technology platform.;
Plainsboro: Novo Nordisk has announced that the U.S. Food and Drug Administration (FDA) has approved Rivfloza (nedosiran) injection 80 mg, 128 mg, or 160 mg, a once-monthly subcutaneous ribonucleic acid interference (RNAi) therapy, to lower urinary oxalate levels in children 9 years of age and older and adults with primary hyperoxaluria type 1 (PH1) and relatively preserved kidney function.
Primary hyperoxaluria (PH) is a rare genetic disease that causes overproduction of oxalate by the liver that is estimated to affect 1 in 38,600 individuals worldwide. PH1 is the most clinically prevalent (roughly ~80% of PH patients) and severe of the three subtypes of PH. PH1 is a progressive metabolic disorder that primarily affects the kidneys and can lead to progressive kidney damage. In the U.S., it is estimated that over 2,000 people are living with PH1.
"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. "We are committed to driving change on behalf of people living with rare diseases and helping address the significant unmet needs of the PH1 community. We look forward to making our first RNAi treatment available to people living with PH1 and the healthcare professionals partnering on their care."
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