Novo Nordisk’ Rivfloza (nedosiran) Receives the US FDA’s Approval for Children Aged ≥9 Years and Adults with Primary Hyperoxaluria Type 1
- The US FDA has approved Rivfloza (80/128/160mg, qm) in children aged ≥9yrs. & adults with PH1 and relatively preserved kidney function. The approval was based on the P-II trial (PHYOX 2) trial evaluating Rivfloza vs PBO in 35 patients with PH1 or PH2 and an eGFR ≥30 mL/min/1.73 m2 along with interim data from P-III extension study (PHYOX 3)
- The (PHYOX 2) trial met its 1EPs & showed a reduction from baseline in 24hr.-urinary oxalate (Uox) excretion from Day 90-180, LS mean difference of AUC24-hour Uox was 4976 significant b/w both groups over 90 days
- In the (PHYOX 3) extension study, reductions in 24hr. Uox excretion was maintained in 13 patients who had received an additional 6mos. of treatment. Rivfloza is an RNAi therapy designed to lower urinary oxalate levels & is expected to be available in early 2024
Ref: PR Newswire | Image: Novo Nordisk
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