Everest Medicines Gets NMPA Acceptance for NEFECON® Supplementary Application

Everest Medicines Gets NMPA Acceptance for NEFECON® Supplementary Application

By, Admin 19 July 2024

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.

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