FDA Approves Novo Nordisk’s Rivfloza, Setting Stage for Market Duel with Alnylam

FDA Approves Novo Nordisk's Rivfloza, Setting Stage for Market Duel with Alnylam

Novo Nordisk, known for its popular obesity therapy Wegovy, has achieved a significant milestone with the FDA approval of Rivfloza, a treatment designed for the rare disease primary hyperoxaluria type 1 (PH1). This announcement underscores Novo’s commitment to addressing rare diseases and expanding its therapeutic portfolio.

Rivfloza is a monthly subcutaneous treatment classified under the ribonucleic acid interference (RNAi) class of drugs. It represents the second FDA-approved option for PH1, following the approval of Alnylam’s rival RNAi therapy Oxlumo in November 2020.

Primary hyperoxaluria type 1 is a rare and severe disease characterized by an excessive production of oxalate, leading to the formation of kidney stones and progressive kidney damage. Novo estimates that approximately 2,000 patients in the United States live with this condition, with many likely remaining undiagnosed.

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Novo Nordisk acquired Rivfloza as part of its acquisition of Dicerna Pharmaceuticals in 2021, a deal valued at $3.3 billion. Rivfloza was the lead candidate in Dicerna’s pipeline at the time of acquisition. Dicerna initially explored the drug’s potential in other forms of primary hyperoxaluria (PH2 and PH3) but ultimately focused on PH1 based on promising early data.

The FDA’s approval of Rivfloza is specifically for the reduction of urinary oxalate levels in PH1 patients aged 9 and older with relatively preserved kidney function. Phase 2 study results demonstrated a significant reduction in urinary oxalate excretion in patients receiving the medication compared to those on a placebo, according to Novo.

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Meanwhile, Alnylam has been actively engaged in launching Oxlumo since its approval in 2020. As of the end of June, over 350 commercial patients worldwide were benefiting from the drug, generating $24.2 million in the second quarter. Notably, Oxlumo is administered subcutaneously every three months, while Novo’s Rivfloza offers the convenience of a monthly therapy. Novo Nordisk has plans to introduce Rivfloza to the market in early 2024, contributing to the advancement of treatments for rare diseases and underscoring the company’s commitment to improving patient outcomes in this challenging therapeutic area.

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