Europe's largest drugs company, Novo Nordisk (NYSE:NVO), told investors its once-monthly injection, Rivfloza, has received approval from the US Food and Drug Administration (FDA) for treating a rare genetic kidney condition known as primary hyperoxaluria.
Rivfloza employs RNA interference technology (RNAi) to silence or neutralise genes that contribute to the disease. It aims to reduce urinary oxalate levels, a natural chemical whose overproduction in the urine is a characteristic of primary hyperoxaluria.
The company plans to make Rivfloza available to qualifying patients early next year, with pricing based on the therapy's proven clinical value and benefits for those suffering from primary hyperoxaluria type 1 (PH1).
The Danish pharma giant acquired the technology for this therapy through its $3.3 billion purchase of Dicerna Pharmaceuticals last year.
The FDA's approval was based on clinical studies showing that Rivfloza effectively reduced 24-hour urinary oxalate levels compared to a predetermined baseline and a placebo. Novo Nordisk (NYSE:NVO) estimates that over 2,000 people in the United States are living with this condition.
The approval follows that of Alnylam Pharmaceuticals (NASDAQ:ALNY)' Oxlumo, which was the first treatment to receive FDA approval for this particular kidney condition.