22 August 2023 | Tuesday | Regulatory
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"We congratulate our partner Calliditas for being granted priority review by the FDA for full approval and taking a step closer to offering this first-in-disease therapy to all IgAN patients at risk of progression. It is another testament to Nefecon® as an important, disease-modifying medicine with significant eGFR treatment benefit observed across the entire study population that can substantially delay onset of dialysis for patients at risk," said Rogers Yongqing Luo, Chief Executive Officer of Everest Medicines. "As IgAN prevalence in Asia is much higher than the rest of the world, we look forward to receiving NDA decision for Nefecon® in mainland China in the second half year and filing NDAs in other Asian territories as soon as possible."
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 full data from the NeflgArd Phase 3 trial was published in The Lancet in August 2023.
The trial demonstrated a statistically significant benefit of Nefecon® over placebo (p-value < 0.0001) 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 approximately 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.