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Everest Medicines Report the NDA Acceptance of Nefecon by the Taiwan FDA for the Treatment of Primary IgA Nephropathy

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Everest Medicines

Everest Medicines Report the NDA Acceptance of Nefecon by the Taiwan FDA for the Treatment of Primary IgA Nephropathy

Shots:

  • The NDA was submitted based on the results from the P-III (NefIgArd) trial evaluating the safety & efficacy of Nefecon (16mg, QD) vs PBO in patients (n=364) with primary IgAN on optimized RASi therapy for a duration of 2yrs
  • The study also analysed the potential difference in response to Nefecon treatment based on self-reported Asian (n=83) or White (n=275) ancestry in patients with IgAN. The 1EP includes a time-weighted average of eGFR over 2yrs.
  • The results showed a difference in 2yrs eGFR slope of 2.95mL/min/ 1.73 m2/year depicting meaningful benefit of Nefecon vs PBO. Moreover, Nefecon also demonstrated a clinically meaningful preservation of kidney function with a reduction in proteinuria & stabilization of eGFR vs PBO

Ref: Everest Medicines | Image: Everest Medicines

Related News:- The NMPA Accepts Everest Medicine's IND Application for Zetomipzomib to Treat Immune Mediated Disorders

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Kritika Jha

Kritika is a content writer at PharmaShots. She is interested in covering recent innovations from the pharma & MedTech industry. She covers news related to Product approvals, clinical trial results, and updates. She can be contacted at connect@pharmashots.com.

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