Everest Medicines Receives Official Acceptance for NEFECON® Supplementary Application from China National Medical Products Administration
Overview
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).
About NEFECON®
- 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.
NEFECON®'s Benefits
- 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.
sNDA Submission
- 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
- 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.
