WASHINGTON (dpa-AFX) - Viatris Inc. (VTRS), a healthcare company, on Monday reported positive top-line results from a Phase 3 study evaluating VR-205 in Japanese adults with primary immunoglobulin A nephropathy (IgAN) who are at risk of progressing to end-stage renal disease.
The study met its primary endpoint, with VR-205, a targeted-release budesonide formulation, demonstrating a 33.75% reduction in geometric mean urine protein-to-creatinine ratio (UPCR) at nine months compared with baseline.
VR-205 was generally well tolerated during the nine-month treatment period, with a safety profile consistent with that observed in non-Japanese patients treated with the drug.
Viatris said it plans to submit a New Drug Application for VR-205 in Japan by the end of 2026.
Under a 2022 licensing agreement with Calliditas Therapeutics AB, Viatris gained exclusive rights to obtain marketing authorization and commercialize VR-205 for the treatment of primary IgAN in Japan.
The therapy is currently approved and marketed as Tarpeyo in the United States and as Kinpeygo in Europe.
Viatris shares closed at $16.33 on Friday, up 1.62%.
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