Everest Medicines Receives Official Acceptance for NEFECON® Supplementary Application from China National Medical Products Administration
Thursday, July 18, 2024
Everest Medicines has announced that the China National Medical Products Administration (NMPA) has accepted a supplemental New Drug Application (sNDA) for NEFECON® based on complete clinical data from the global Phase 3 NeflgArd study. This marks a significant step towards full approval for NEFECON® as a treatment for IgA nephropathy (IgAN).
NEFECON® was first granted accelerated approval by the China NMPA in November 2023 for treating primary IgAN in adults at risk of disease progression. The U.S. FDA also approved NEFECON® delayed release capsules for adults with primary IgAN who are at risk for disease progression, irrespective of proteinuria levels.
Everest Medicines, highlighted NEFECON®'s innovative benefits as the first treatment tailored specifically for IgAN. IgAN is particularly prevalent in Asia, where patients face a heightened risk of progressing to end-stage renal disease. Since its introduction in China, NEFECON® has introduced new standards in IgAN management. With millions of new IgAN cases diagnosed annually in China alone, there exists a substantial unmet medical need.
The submission of the sNDA is supported by data from the global Phase 3 NefIgArd trial, a randomized, double-blind study that assessed NEFECON®'s efficacy and safety compared to placebo in adults with primary IgAN who were already receiving optimized RASi therapy. The trial demonstrated significant improvements in kidney function and durable reductions in proteinuria with NEFECON® treatment, both globally and specifically in the Chinese patient subset.
NEFECON® is an oral, delayed release formulation of budesonide, designed to target mucosal B-cells in the ileum, the site of IgAN pathology. Everest Medicines holds exclusive development and commercialization rights for NEFECON® in several Asian territories through a licensing agreement with Calliditas Therapeutics.
The acceptance of NEFECON®'s sNDA by the NMPA underscores its potential to address critical unmet needs in IgAN treatment, potentially expanding access pending full approval.
Source: everestmedicines.com
