Everest Medicines Secures NDA Approval for Nefecon® in Hong Kong, Expanding Treatment Reach in Asia

02 May 2024 | Thursday | News

Following approvals in Singapore, Macau, and mainland China, Nefecon® gains approval in Hong Kong for treating IgA nephropathy, with promising results from global and regional clinical trials
Image Source : Public Domain

Image Source : Public Domain

Everest Medicines announced that the Hong Kong Department of Health had approved Nefecon® for the treatment of primary immunoglobulin A nephropathy (IgAN) in adults at risk of disease progression. Hong Kong marks the fourth region in Everest territories that Nefecon® received New Drug Application (NDA) approval after SingaporeMacau and mainland China. Nefecon® received full U.S. Food and Drug Administration (FDA) 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 Rogers Yongqing Luo, Chief Executive Officer of Everest Medicines. "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 TaiwanChina, to bring this first-in-disease therapy to more patients."

In the 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. The reduction in UPCR observed with Nefecon® treatment was also durable and the proportion of patients with microhematuria in the Nefecon group declined. Nefecon® was also generally well-tolerated in the Phase 3 clinical trial.

Further subpopulation analysis from the NefIgArd clinical trial showed a numerically greater treatment effect in kidney function prevention, proteinuria reduction and microhematuria improvement in the Chinese subpopulation compared to 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 a 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.  In the global population, Nefecon® treatment provided an approximately 30% greater reduction in UPCR at both 24 months and 9 months compared to placebo. The proportion of Chinese patients without microhematuria in the Nefecon® group increased from 26.9% at baseline to 57.7% during observational follow-up, while it was maintained at 14.3% in the placebo group.

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