Rivfloza FDA Approval History
Last updated by Judith Stewart, BPharm on Oct 26, 2023.
FDA Approved: Yes (First approved September 29, 2023)
Brand name: Rivfloza
Generic name: nedosiran
Dosage form: Injection
Company: Novo Nordisk
Treatment for: Primary Hyperoxaluria
Rivfloza (nedosiran) is a lactate dehydrogenase A (LDHA) directed small interfering RNA used to lower urinary oxalate levels in patients with primary hyperoxaluria type 1 (PH1).
- Rivfloza is indicated 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, e.g., eGFR ≥ 30 mL/min/1.73 m2.
- Primary hyperoxaluria type 1 (PH1) is the most common of the three subtypes of primary hyperoxalurias, which are rare genetic disorders of hepatic glyoxylate metabolism. PH1 is caused by mutations in the alanine glyoxylate aminotransferase (AGXT) gene, resulting in excess oxalate in the body and the formation of kidney stones, which may lead to chronic kidney damage.
- Rivfloza works in the treatment of PH1 by reducing the levels of hepatic lactate dehydrogenase to reduce the production of oxalate by the liver.
- FDA approval of Rivfloza was based on results of the pivotal phase 2 PHYOX2 clinical trial and interim data from the phase 3 PHYOX3 extension study. PHYOX2 was a pivotal, randomized, double-blind trial comparing Rivfloza and placebo. PHYOX2 met its primary endpoint, showing that patients treated with Rivfloza achieved a marked reduction from baseline in 24 hour-urinary oxalate (Uox) excretion from Day 90 to Day 180. Interim results from the PHYOXTM3 extension study showed reductions in 24-hour Uox excretion were maintained in the patients who had received an additional six months of treatment with Rivfloza.
- Rivfloza is administered by subcutaneous injection once a month.
- Common adverse reactions include injection site reactions.
Development timeline for Rivfloza
| Date | Article |
|---|---|
| Oct 2, 2023 | Approval FDA Approves Rivfloza (nedosiran) for the Treatment of Primary Hyperoxaluria Type 1 (PH1) |
Further information
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