Taiwan TFDA Approves Nefecon for Primary IgA Nephropathy Treatment
核心洞察
The Taiwan Food and Drug Administration (TFDA) has approved NEFECON (搜索)® for treating primary immunoglobulin A nephropathy (IgAN) in adults at risk of disease progression.
NEFECON (搜索)®, already approved by the U.S. FDA, is the first IgAN etiological treatment drug to receive full approval, now expanding to more IgAN patients.
Clinical trials demonstrated NEFECON (搜索)®'s ability to reduce proteinuria (搜索), microscopic hematuria, and significantly improve estimated glomerular filtration rate (eGFR) compared to placebo (p<0.0001).
Everest Medicines (搜索) announced that the Taiwan Food and Drug Administration (TFDA) has approved NEFECON (搜索)® for reducing kidney function loss in adult patients with primary immunoglobulin A nephropathy (IgAN) who are at risk for disease progression. This approval expands the reach of NEFECON®, the first fully FDA-approved IgAN etiological treatment, to a broader patient population.
Rogers Yongqing Luo, CEO of Everest Medicines (搜索), stated that this approval marks another milestone for NEFECON (搜索)®, following approvals in Singapore, Hong Kong, and its commercial launch in Mainland China. He emphasized the high prevalence of IgAN in the Asian population, where there is a 56% higher risk of progression to end-stage renal disease, highlighting the significant unmet clinical need.
Clinical Trial Data
The global Phase 3 NefIgArd clinical trial demonstrated that NEFECON (搜索)® significantly improved patient outcomes compared to placebo. Patients treated with NEFECON® experienced a sustained reduction in proteinuria (搜索) and a decreased frequency of microscopic hematuria. Furthermore, the trial showed clinically relevant and statistically significant benefits in estimated glomerular filtration rate (eGFR) (p<0.0001), with a 50% reduction in the decline of kidney function. This suggests that NEFECON® could potentially delay the progression to dialysis or kidney transplantation by 12.8 years.
The NefIgArd study, a randomized, double-blind, multicenter trial, evaluated NEFECON (搜索)® (16 mg/day) against placebo in adults with primary IgA nephropathy (搜索) already treated with optimized RAS inhibitors. The study included a 9-month treatment period followed by a 15-month drug withdrawal follow-up.
Regional Approvals and Future Plans
Taiwan is the fifth region within Everest Medicines (搜索)' authorized territories to approve NEFECON (搜索)®, joining Macau, Mainland China, Singapore, and Hong Kong. A new drug application for NEFECON® was also submitted in South Korea at the end of 2023. In mainland China, the first prescription for NEFECON® was issued in May, and a supplemental new drug application seeking full approval based on the complete Phase 3 NefIgArd study data has been accepted.
NEFECON (搜索)® is also anticipated to be included in the first Chinese IgAN guidelines, where it is expected to be recommended as a first-line treatment for IgAN patients at risk of disease progression.
About NEFECON
NEFECON (搜索)® is an oral, delayed-release formulation of budesonide, a corticosteroid known for its potent glucocorticoid activity. The formulation is designed to release budesonide in the distal ileum, targeting mucosal B-cells where the disease originates, according to current pathogenesis models. Everest Medicines (搜索) holds exclusive rights to develop and commercialize NEFECON® in several Asian markets under a licensing agreement with Calliditas Therapeutics.