Health department greenlights Nefecon for adult IgAN Patients

Hong Kong is the fourth jurisdiction that approved the use of Nefecon.

The Department of Health has approved Nefecon use for treating primary immunoglobulin A nephropathy (IgAN) in adults at risk of disease progression.

The drug’s developer, Everest Medicines, said Hong Kong is the fourth region in Everest territories that Nefecon received new drug application approval, following Singapore, Macau and mainland China. 

The drug received full US Food and Drug Administration approval in December 2023.

"IgAN is prevalent in the Asian population, which has 53% higher risks of progression to end-stage renal disease and faster disease progression," said Everest Medicines CEO Rogers Yongqing Luo.

"With the NDA approval of Nefecon in Hong Kong, we will continue to expand its access across Asian territories, including actively promoting the commercial launch of Nefecon® in mainland China and securing approvals in South Korea and Taiwan, China, to bring this first-in-disease therapy to more patients,” he added.

ALSO READ: Hong Kong and Shanghai eye stronger healthcare collaboration

In its global Phase 3 NefIgArd clinical trial, Nefecon demonstrated a “highly statistically significant and clinically meaningful benefit compared to placebo in estimated glomerular filtration rate (eGFR) over the two-year period.”

Experts also saw that the reduction in Urine Protein Creatinine Ratio (UPCR) with Nefecon treatment was durable, and the proportion of patients with microhematuria in the Nefecon group declined. 

Moreover, the treatment was generally well-tolerated in the Phase 3 clinical trial.

The NefIgArd clinical trial also showed a numerically greater treatment effect in kidney function prevention, proteinuria reduction, and microhematuria improvement in the Chinese subpopulation versus the global population.

“The mean absolute change from baseline in eGFR at 24 months showed approximately 66% less deterioration in kidney function with 9-month Nefecon treatment compared with smaller preservation of kidney function (50%) in the global population. Patients treated with Nefecon in China showed a 43% greater reduction (95% CI 8%, 65%) in UPCR compared with placebo at 24 months and a 31% greater reduction (95% CI 0, 53) at 9 months,” Everest Medicines added.