Shanghai-based biopharmaceutical company Everest Medicines has announced that its New Drug Application (NDA) for Nefecon® has been accepted for review by the Taiwan Food and Drug Administration (TFDA). This application aims to seek approval for the treatment of primary immunoglobulin A nephropathy (IgAN) in adult patients. Nefecon® was previously approved for IgAN treatment in the U.S., European Union, and mainland China, marking it as the first-ever treatment for IgAN in these regions.
Rogers Yongqing Luo, the Chief Executive Officer of Everest Medicines, expressed satisfaction with the rapid expansion of Nefecon®’s regulatory approvals, including recent acceptances in China and South Korea. Emphasizing the prevalence of IgAN in the Asian population and the associated risk of progression to end-stage renal diseases, Luo anticipates approval in Taiwan in 2024.
The Taiwan Food and Drug Administration granted Accelerated Approval Designation (AAD) to Nefecon® in November 2022. Everest’s licensing partner, Calliditas Therapeutics AB, confirmed on December 20 that Nefecon® is now the first and only fully FDA-approved treatment for IgAN, based on a measure of kidney function.
The Phase 3 NefIgArd clinical trial assessed Nefecon® at a once-daily dose of 16 mg compared to a placebo in adult patients with primary IgAN on optimized RASi therapy. The trial, spanning two years, demonstrated a statistically significant and clinically meaningful benefit of Nefecon® over placebo in preserving kidney function. The trial’s primary endpoint, the time-weighted average of eGFR over two years, showed positive results, as did the difference in the 2-year total eGFR slope. These findings were consistent across the entire study population, irrespective of UPCR baseline level.
Further analysis of the full two-year results of the NefIgArd trial, involving 364 patients, revealed clinically meaningful preservation of kidney function in both Asian and White ancestry subgroups. Treatment with Nefecon® at 16 mg/day over a 9-month period resulted in a reduction in proteinuria and stabilization of eGFR in comparison to the placebo group.
With similar trials ongoing across the globe, Everest Medicines looks forward to offering Nefecon® to patients across Asia, including Singapore, Hong Kong, Taiwan, and South Korea in 2024, with a particular emphasis on addressing the needs of the five million IgAN patients in Mainland China.