Calliditas Receives FDA Priority Review For Full Approval Of Nefecon For IgA Nephropathy Treatment

(RTTNews) - Everest Medicines said that U.S. Food and Drug Administration has accepted the submission for the supplemental New Drug Application or sNDA for Nefecon from its partner Calliditas Therapeutics AB (CALT) and granted Priority Review.

The Prescription Drug User Fee Act (PDUFA) goal date is December 20, 2023.

The sNDA is based on the full data set from the Phase 3 NefIgArd clinical trial, a randomized, double-blind, multicenter study evaluating the efficacy and safety of Nefecon at a once-daily dose of 16 mg, compared to placebo, in adult patients with primary IgAN on optimized RASi therapy.

The trial demonstrated a statistically significant benefit of Nefecon over placebo in estimated glomerular filtration rate (eGFR) over the two-year study period, which consisted of nine months of treatment with Nefecon or placebo, followed by a 15-month follow-up period off the study drug. The data reflected treatment benefits across the entire study population, regardless of UPCR baseline, and showed a difference between TARPEYO and placebo in 2-year eGFR total slope of about 3mL/min per year using a robust regression method of analysis.

The China National Medical Products Administration (NMPA) accepted Everest's NDA for Nefecon for the treatment of IgAN in November 2022, with a decision expected in the second half year of 2023. The NMPA has also granted Nefecon break-through therapy designation and NDA priority review. Nefecon was the first non-oncology drug to receive break-through therapy designation in China.

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