Viatris Inc. (Nasdaq: VTRS) is targeting submission of a New Drug Application to Japan's Ministry of Health, Labour and Welfare (MHLW) for Tarpeyo/Kinpeygo (VR-205, targeted-release budesonide), seeking approval for the treatment of primary immunoglobulin A nephropathy (IgAN) in Japanese adults at risk of developing end-stage renal disease. The company said the filing is targeted by the end of 2026 and would represent the first IgAN-specific, targeted-release budesonide oral therapy in Japan, where the disease is classified as a designated intractable condition.
The planned submission follows positive top-line results from the Phase III bridging study VR-205A-01-CAZ-3001, a multicenter, interventional, open-label trial enrolling 39 Japanese adult patients with primary IgAN. The study was designed to evaluate efficacy and safety of 16 mg VR-205 daily over a nine-month treatment period, followed by a three-month follow-up. No details on priority review status or a formal PDUFA-equivalent target date have been disclosed, the company said.
The trial met its primary endpoint, with VR-205 demonstrating a 33.75% reduction in geometric mean urine protein-to-creatinine ratio (UPCR) at nine months compared to baseline (95% CI: -45.27 to -19.80; p<0.05). Key secondary endpoints were also met, including statistically significant and clinically meaningful UPCR reductions at six and twelve months, improvements in estimated glomerular filtration rate and serum creatinine, reductions in urine albumin-to-creatinine ratio, and improvements in microhematuria. No study participants progressed to dialysis, kidney transplant, or severe renal impairment by end of study. The safety profile was consistent with the established profile of targeted-release budesonide in non-Japanese populations. The efficacy and safety profile observed in Japanese patients was reported as consistent with that seen in the global NefIgArd trial, which supported approvals in the US and EU. Viatris holds commercialization rights in Japan under a 2022 exclusive license agreement with Sweden-based Calliditas Therapeutics AB.