Everest Medicines has received approval from China’s National Medical Products Administration for its therapy, Nefecon, to treat primary immunoglobulin A nephropathy (IgAN) in adult patients.
Nefecon is the first therapy to be approved by the European Medicines Agency and the US Food and Drug Administration for IgAN.
IgAN affects an estimated five million individuals in China, the country with the highest prevalence of primary glomerular diseases.
Nefecon is the first non-oncology medication to receive breakthrough therapy designation in the country, accompanied by priority review approval.
In the Phase III NefIgArd clinical study, the company assessed the safety and efficacy of the drug at a once-daily 16mg dose compared to placebo in adults with primary IgAN on optimised RASi therapy.
In the global, double-blind and multicentre study, Nefecon showed benefit against placebo in estimated glomerular filtration rate over a two-year period consisting of nine months of treatment and 15 months of follow-up.
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Chinese subpopulation analysis showed a numerically greater magnitude of Nefecon treatment effect versus placebo in kidney function, proteinuria and microhematuria.
Everest Medicines CEO Rogers Yongqing Luo stated: “The NDA approval of Nefecon in China is not only a significant milestone for Everest, but also a landmark for Chinese IgAN patients who will finally have an approved drug with an IgAN indication to treat their illness.
“Chinese patients have higher incidence rates of IgAN and faster disease progression than the rest of the world. They have an urgent need for innovative therapies like Nefecon to target disease origin and delay disease progression.”
In August 2023 the FDA accepted a supplemental new drug application submission from the company’s partner, Calliditas Therapeutics, for the full approval of Nefecon.