Everest Medicines Receives Taiwan TFDA Approval for NEFECON® to Treat IgA Nephropathy
Monday, October 21, 2024
Everest Medicines has announced the approval of NEFECON® by Taiwan’s Food and Drug Administration (TFDA).
NEFECON® is a patented, delayed-release oral formulation of budesonide, a corticosteroid designed to target mucosal B-cells in the ileum, where IgAN originates.
NEFECON® is now approved for reducing kidney function decline in adult patients with primary immunoglobulin A nephropathy (IgAN) at risk of disease progression.
This approval broadens access to NEFECON®, the first and only IgAN treatment fully approved by the U.S. FDA, to more patients, with no restrictions based on proteinuria levels.
The global Phase 3 NefIgArd trial, a two-year, randomized, double-blind, placebo-controlled study, evaluated the safety and efficacy of NEFECON® in IgAN patients.
The trial, which included participants from both Asian and Caucasian backgrounds, found that NEFECON® significantly delayed the decline in eGFR and reduced proteinuria across both groups, demonstrating its effectiveness in protecting kidney function.
Everest Medicines holds the exclusive rights to develop and commercialize NEFECON® in several territories, including Mainland China, Hong Kong, Taiwan, and Singapore, under a license agreement with Calliditas Therapeutics.
The agreement was extended in 2022 to include South Korea.
NEFECON® has already been approved in Singapore, Hong Kong, and Mainland China. IgAN is particularly prevalent among Asian populations, who face a 56% higher risk of progressing to end-stage renal disease. As a result, there is a significant unmet clinical need for effective treatments in this region.
The global Phase 3 NefIgArd trial demonstrated that NEFECON® provided sustained reductions in proteinuria and hematuria, as well as a 50% slower decline in kidney function compared to placebo. It also indicated that NEFECON® could delay the need for dialysis or kidney transplantation by approximately 12.8 years.
Taiwan marks the fifth region within Everest Medicines' territory to approve NEFECON®, following approvals in Macau, Mainland China, Singapore, and Hong Kong. The drug is also undergoing regulatory review in South Korea and has been prescribed in Mainland China since May 2023.
NEFECON® is expected to receive full approval in China soon, following submission of a supplemental new drug application. The drug is also likely to be included in Chinese guidelines for IgAN as the recommended first-line treatment for patients at risk of disease progression.
Source: everestmedicines.com
