Everest Medicines' NEFECON®: A Breakthrough in IgA Nephropathy Treatment in South Korea

Everest Medicines, a leading biopharmaceutical company, has announced that its innovative drug, NEFECON®, has received full approval from South Korea's Ministry of Food and Drug Safety (MFDS) for the treatment of primary immunoglobulin A nephropathy (IgAN). This marks a significant milestone in the fight against this prevalent kidney disease, particularly in Asian countries.

IgAN is a kidney disease characterized by the deposition of immunoglobulin A (IgA) in the kidneys, leading to inflammation and damage. It is the most common form of glomerulonephritis worldwide, with a higher prevalence among Asian populations. In South Korea, approximately 1.5% of the population is affected by IgAN, highlighting the urgent need for effective treatments.

NEFECON®, a patented oral, delayed release formulation of budesonide, targets the disease's origin by targeting mucosal B-cells present in the ileum. The drug has demonstrated remarkable efficacy in clinical trials, showing a sustained reduction in proteinuria and a significant delay in the decline of estimated glomerular filtration rate (eGFR). Moreover, NEFECON® has been well-tolerated, with a safety profile comparable to placebo.

The full approval of NEFECON® in South Korea is based on the global Phase 3 NefIgArd clinical trial, which showed that compared to placebo, NEFECON® brought about a sustained reduction in proteinuria and reduced the frequency of microscopic hematuria. Additionally, the drug demonstrated clinically relevant and statistically significant treatment benefits in eGFR, reducing the decline in kidney function by 50% over a period of 2 years.

The approval of NEFECON® in South Korea is expected to have a significant impact on the treatment landscape for IgAN. With a high prevalence of the disease in the country, the drug's efficacy and safety profile make it an attractive option for patients and healthcare providers alike. Moreover, the MFDS's Global Innovative product on Fast Track (GIFT) designation has accelerated the regulatory review time by 25%, allowing for a quicker launch in South Korea.

Everest Medicines' commitment to expanding NEFECON®'s regulatory approvals across its licensing territories is commendable. The company's focus on addressing the urgent needs of IgAN patients in Asia, particularly in South Korea, is a testament to its dedication to improving the lives of those affected by this debilitating disease.

In conclusion, the full approval of NEFECON® in South Korea is a significant breakthrough in the treatment of primary IgA nephropathy. With a high prevalence of the disease in the country and a compelling efficacy and safety profile, NEFECON® is poised to become a game-changer in the fight against IgAN. Everest Medicines' commitment to expanding the drug's reach across Asia is a step in the right direction towards improving the lives of millions of patients affected by this disease.