Everest Medicines Announces the Approval of New Drug Applications for Nefecon® in the Treatment of Primary IGA Nephropathy Among Adult Patients in South Korea
Friday, December 01, 2023
Everest Medicines (HKEX: 1952.HK), a biopharmaceutical firm specializing in the development, manufacturing, and commercialization of innovative medicines and vaccines, has revealed that its New Drug Application (NDA) for Nefecon® has been accepted for review by South Korea's Ministry of Food and Drug Safety (MFDS). The application focuses on the treatment of primary immunoglobulin A nephropathy (IgAN) in adult patients. Nefecon® stands as the initial targeted treatment for IgAN to secure approval in the United States, European Union, and China. The company foresees NDA approval in South Korea by 2024.
Everest Medicines, expressed the company's dedication to securing regulatory approvals for Nefecon® in East Asian regions, given the elevated prevalence of IgAN in this demographic. He conveyed the company's objective to promptly introduce Nefecon® to patients in various Asian territories, including Singapore, Hong Kong, Taiwan, and South Korea, within the next year to address the pressing need for innovative therapies targeting disease origin and delaying progression.
The MFDS in South Korea granted Global Innovative product on Fast Track (GIFT) designation to Nefecon® earlier, making it the first non-oncology product included in the GIFT program. This designation is expected to expedite the regulatory review process by 25% through a rolling review mechanism.
The Phase 3 NefIgArd clinical trial, a randomized, double-blind, multicenter study, demonstrated the efficacy and safety of Nefecon® at a once-daily dose of 16 mg compared to placebo in adult patients with primary IgAN on optimized RASi therapy. The trial, spanning two years, showcased significant benefits of Nefecon® over placebo in terms of the time-weighted average of eGFR over 2 years, demonstrating a statistically significant and clinically meaningful advantage (p-value < 0.0001). The study also revealed a favorable difference in the 2-year total eGFR slope in favor of Nefecon®.
The NefIgArd trial's two-year results, analyzed based on self-reported Asian (n=83) or White (n=275) ancestry, indicated that Nefecon® treatment led to a clinically meaningful preservation of kidney function in both subgroups, with a reduction in proteinuria and stabilization of eGFR compared to placebo.
Nefecon® is a patented oral, delayed-release formulation of budesonide, a corticosteroid designed to target mucosal B-cells in the ileum where IgAN originates. Everest Medicines holds exclusive rights for Nefecon® in Mainland China, Hong Kong, Macau, Taiwan, Singapore, and, following an extension in March 2022, South Korea, through a license agreement with Calliditas.
Source: prnasia.com
