Friday, October 27, 2023
Everest Medicines, a biopharmaceutical company dedicated to developing, manufacturing, and distributing innovative medicines and vaccines, has announced that the Pharmaceutical Administration Bureau of the Macau Special Administrative Region of China has given its approval for the New Drug Application (NDA) for Nefecon®. This marks a significant milestone as it is the first region within Everest's territory to grant NDA approval for Nefecon®, a groundbreaking treatment for primary immunoglobulin A nephropathy (IgAN) in adults at risk of disease progression.
Everest Medicines, expressed excitement about the approval, highlighting that Nefecon® is the world's first FDA and EMA-approved treatment for IgA nephropathy. This achievement represents the initiation of a new era in IgA nephropathy treatment in the region. The company is now working to secure approvals for Nefecon® in mainland China and Singapore this year, followed by Hong Kong, South Korea, and Taiwan next year.
IgA nephropathy is the most prevalent primary glomerular disease in China, often affecting individuals at a young age with a poor prognosis. Many IgAN patients are at risk of kidney failure due to disease progression. Professor Zhang Hong, a member of the global steering committee for the Phase 3 clinical study NefIgArd, emphasized the potential of Nefecon® to reduce kidney function decline and delay the need for dialysis or kidney transplantation. The approval of Nefecon® in Macau is a significant step toward providing this innovative therapy to Chinese IgAN patients.
The Phase 3 NefIgArd clinical trial, a randomized, double-blind, multicenter study, assessed the efficacy and safety of Nefecon® at a once-daily dose of 16 mg compared to a placebo in adult patients with primary IgAN already on optimized RASi therapy. The results of the study showed a statistically significant and clinically meaningful benefit of Nefecon® over placebo in terms of the time-weighted average of eGFR over two years and a difference in the 2-year total eGFR slope in favor of Nefecon®. This benefit was observed across the entire study population, regardless of the baseline UPCR level.
Nefecon® is already approved and available in the United States, the European Union, and the UK. The NDA for Nefecon® in mainland China is currently under Priority Review, and it was the first non-oncology medicine to receive Breakthrough Therapy Designation in China. An early-access program for Nefecon® has been in place at Shanghai Ruijin Hospital's Hainan subsidiary since April 2023.
Nefecon® is a patented oral, delayed-release formulation of budesonide, a corticosteroid that primarily targets mucosal B-cells in the ileum, the site of origin for IgAN, thanks to its enteric-coated beads. Everest Medicines holds exclusive rights to develop and commercialize Nefecon® in Mainland China, Hong Kong, Macau, Taiwan, Singapore, and South Korea through an agreement with Calliditas.
Source: prnewswire.com
