Everest Medicines announced that the Pharmaceutical Administration Bureau of the Macau Special Administration Region, China, has approved its New Drug Application (NDA) for Nefecon® for the treatment of primary immunoglobulin A nephropathy (IgAN) in adults at risk of disease progression. Macau is the first region in Everest territories that received Nefecon® NDA approval. The Phase 3 NefIgArd clinical trial, a randomized, double-blind, multicenter study, evaluated 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 NefIgArd study is a 2-year trial, which consisted of nine months of treatment with Nefecon® or placebo, followed by a 15-month follow-up period off study drug. The primary endpoint, time-weighted average of eGFR over 2 years, showed a statistically significant and clinically meaningful benefit of Nefecon® over placebo (p-value < 0.0001). It also showed a difference in 2-year total eGFR slope of 2.95 mL/min per 1.73 m2 per year in favor of Nefecon®.

The data reflected treatment benefits across the entire study population, regardless of UPCR baseline level.