Everest Medicines, a biopharmaceutical company specializing in the development, manufacturing, and commercialization of innovative treatments, has announced that its drug NEFECON® has received full approval from the Ministry of Food and Drug Safety (MFDS) in South Korea. The drug is now authorized for the treatment of adults with primary immunoglobulin A nephropathy (IgAN) who have urine protein excretion of ≥1.0 g/day (or a urine protein-to-creatinine ratio ≥0.8 g/g). This approval marks an important step in expanding the availability of NEFECON® across Asia, offering new hope to patients with IgAN in South Korea.
Rogers Yongqing Luo, CEO of Everest Medicines, said, “As the first and only FDA-approved treatment specifically for IgAN, NEFECON® will provide a crucial new option for patients in South Korea. IgAN is particularly prevalent in Asian populations, who have a 56% higher risk of developing end-stage kidney disease compared to other groups, and the condition tends to progress more quickly. We are dedicated to making NEFECON® more accessible and affordable throughout Asia to address the pressing needs of IgAN patients.”
The approval is based on the global Phase 3 NefIgArd clinical trial, which demonstrated that NEFECON® significantly reduced proteinuria, lowered the incidence of microscopic hematuria, and improved the estimated glomerular filtration rate (eGFR). NEFECON® slowed kidney function decline by 50% over two years, including nine months of treatment and 15 months of follow-up, potentially delaying the need for dialysis or kidney transplant by 12.8 years.
A further analysis of the NefIgArd study examined the differences in responses between (n=83) Asian patients and (n=275) Caucasian patients. The results showed that NEFECON® effectively protected kidney function and reduced proteinuria in both groups. Since May this year, NEFECON® has been prescribed in mainland China and has received approval in Macau, Hong Kong, Taiwan, and Singapore, where it is marketed under the name Nefegan®. In July, China’s National Medical Products Administration accepted the final clinical trial data for review, and NEFECON® is expected to be the first fully approved treatment for IgAN in China.