Viatris' VR-205 Reports 33.75% UPCR Drop, Targets NDA Submission by End 2026
VTRS•Viatris’ Phase 3 trial of VR-205 in Japanese adults with primary IgA nephropathy achieved a 33.75% reduction in geometric mean urine protein-to-creatinine ratio at nine months (95% CI: –45.27 to –19.80; p<0.001) with no patients progressing to dialysis. The company plans submission of a Japanese NDA by end of 2026.
1. Phase 3 Clinical Trial Results
Viatris conducted a multicenter, open-label Phase 3 trial enrolling 39 Japanese adults with primary IgA nephropathy at risk of end-stage renal disease. Patients treated with 16 mg daily VR-205 for nine months showed a 33.75% reduction in geometric mean UPCR at nine months versus baseline (95% CI –45.27 to –19.80; p<0.001) along with significant improvements in estimated glomerular filtration rate and urine albumin-to-creatinine ratio.
2. Safety and Tolerability Profile
VR-205 was generally well tolerated over the nine-month treatment period, with adverse events consistent with the known profile of targeted-release budesonide. No participants progressed to dialysis, kidney transplantation or severe renal impairment (eGFR ≤15 mL/min/1.73 m2) by the end of the study.
3. Regulatory and Commercial Next Steps
Viatris aims to submit a Japanese NDA for VR-205 by end of 2026 under an exclusive license agreement for Japan. Approval could position VR-205 as the first oral targeted-release budesonide therapy for primary IgAN in a market with the world’s highest incidence at 39–45 cases per million annually.
