Everest Medicines Limited announced that its New Drug Application (NDA) for Nefecon® has been accepted for review by the Taiwan Food and Drug Administration (TFDA) for the treatment of primary immunoglobulin A nephropathy (IgAN) in adult patients. Nefecon® was the first ever treatment for IgAN approved in U.S., European Union and mainland China. Everest expects approval of Nefecon® in Taiwan in 2024.

The Taiwan Food and Drug Administration granted Accelerated Approval Designation (AAD) to Nefecon® in Nov. 2022. Everest's licensing partner Calliditas Therapeutics AB announced on Dec.

20 that Nefecon® is now the first and only fully FDA-approved treatment for IgAN based on a measure of kidney function. 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.