Wednesday, December 27, 2023
Everest Medicines (HKEX 1952.HK) has declared that the Taiwan Food and Drug Administration (TFDA) has accepted its New Drug Application (NDA) for Nefecon® for the treatment of primary immunoglobulin A nephropathy (IgAN) in adult patients. Nefecon® is the first treatment for IgAN approved in the U.S., European Union, and mainland China. The company expects approval in Taiwan in 2024.
Rogers Yongqing Luo, CEO of Everest Medicines, expressed satisfaction with the expansion to Taiwan after recent NDA approvals in China and NDA acceptance in South Korea. The Asian population has a high prevalence of IgAN, posing a significant risk of progression to end-stage renal diseases.
Nefecon® received Accelerated Approval Designation (AAD) from the Taiwan FDA in Nov. 2022. The Phase 3 NefIgArd clinical trial demonstrated statistically significant and clinically meaningful benefits of Nefecon® over placebo in preserving kidney function for patients with IgAN.
The full two-year results of the NefIgArd trial, involving 364 patients, showed clinically meaningful preservation of kidney function in both Asian and White subgroups. Everest Medicines aims to offer Nefecon® to patients in various Asian territories in 2024, including Singapore, Hong Kong, Taiwan, and South Korea.
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 to develop and commercialize Nefecon® in Mainland China, Hong Kong, Macau, Taiwan, Singapore, and, as of March 2022, South Korea, through a licensing agreement with Calliditas Therapeutics AB.
Source: prnewswire.com
