Everest Medicines has received China’s National Medical Products Administration (NMPA) approval for Nefecon to treat primary immunoglobulin A nephropathy (IgAN) in adults, who are at risk of disease progression.

Nefecon is a patented, oral delayed-release formulation of budesonide, a corticosteroid with potent glucocorticoid activity and weak mineralocorticoid activity.

The drug is designed as an enteric-coated capsule to ensure that it remains intact until it releases budesonide to the distal ileum.

The capsules containing beads coated with budesonide will target mucosal B-cells in the ileum, where IgAN originates as per most of the pathogenesis models.

According to the Chinese biopharmaceutical company, Nefecon is the first IgAN treatment approved by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA).

Everest Medicines CEO Rogers Yongqing Luo said: “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. I would like to extend my gratitude to the regulators, experts, and our staff that made today’s approval possible.

“The NDA approval further establishes our leadership position in nephrology. While the Company will actively prepare for the commercial launch of Nefecon and bring this first-in-disease therapy to patients in China as soon as possible, we will also continue to develop other innovative drug candidates in renal and auto-immune diseases to benefit more Chinese and Asian patients.”

In June 2019, Everest reached an exclusive licence agreement with Swedish drugmaker Calliditas to develop and market Nefecon in China, Hong Kong, Macau, Taiwan and Singapore.

The licence agreement was extended in March last year to include South Korea.

In the Phase 3 NefIgArd clinical trial, Nefecon showed a highly statistically significant and clinically relevant benefit compared to placebo, in adult patients with primary IgAN.

The treatment with Nefecon over a period of two years nine months, and 15 months of follow-up, the drug showed improvement in estimated glomerular filtration rate (eGFR).

Nefecon also resulted in a reduction in urine protein creatinine ratio (UPCR) with durable treatment and a decline in the proportion of patients with microhematuria in the Nefecon group.

According to the analysis of the study results, the Chinese subpopulation had a greater effect of Nefecon treatment in kidney function, proteinuria and microhematuria, compared with placebo.

Nefecon was generally well tolerated in the Chinese population, with a safety profile that was generally consistent with the larger global study of the drug, said the Chinese drugmaker.

In August this year, the US FDA accepted Calliditas Therapeutics’ supplemental New Drug Application (sNDA) for Nefecon and granted Priority Review.