Everest Medicines (HKEX: 1952.HK) has announced that the U.S. Food and Drug Administration (FDA) has accepted the submission for the supplemental New Drug Application (sNDA) for Nefecon® from its partner Calliditas Therapeutics AB (Nasdaq: CALT, Nasdaq Stockholm: CALTX) and has granted Priority Review. The Prescription Drug User Fee Act (PDUFA) goal date is set for December 20, 2023.

Rogers Yongqing Luo, CEO of Everest Medicines, congratulated Calliditas for the Priority Review granted by the FDA, emphasizing the significance of Nefecon® as a groundbreaking therapy for IgA nephropathy (IgAN) patients at risk of progression. Nefecon® has shown substantial eGFR treatment benefits across the entire study population, significantly delaying the onset of dialysis for those at risk. Luo also highlighted the prevalence of IgAN in Asia and expressed anticipation for the NDA decision for Nefecon® in mainland China in the second half of the year, along with plans for filing NDAs in other Asian territories.

The sNDA is based on comprehensive data from the Phase 3 NefIgArd clinical trial, which evaluated the efficacy and safety of Nefecon® in adult patients with primary IgAN on optimized RASi therapy. The trial demonstrated a statistically significant improvement in estimated glomerular filtration rate (eGFR) with Nefecon® over placebo (p-value < 0.0001) over a two-year period. The data indicated treatment benefits across the entire study population, regardless of baseline UPCR, showing a difference between Nefecon® and placebo in 2-year eGFR total slope.

The China National Medical Products Administration (NMPA) accepted Everest's NDA for Nefecon® for IgAN treatment in November 2022, with a decision expected in the second half of 2023. Nefecon® has also received break-through therapy designation and NDA priority review from the NMPA.

Nefecon® is a patented oral delayed-release formulation of budesonide, designed to target mucosal B-cells present in the ileum, where the disease originates. Everest Medicines entered into an exclusive license agreement with Calliditas for development and commercialization rights of Nefecon® in several Asian territories.

Everest Medicines focuses on developing, manufacturing, and commercializing transformative pharmaceutical products and vaccines to address unmet medical needs in Asian markets. The company's therapeutic areas of interest include renal diseases, infectious diseases, mRNA platforms, and autoimmune disorders.

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