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Viatris Reports Successful Phase 3 Trial for IgAN Drug in Japan

Viatris Reports Successful Phase 3 Trial for IgAN Drug in Japan

Viatris has announced positive top-line results from a Phase 3 study of VR-205, a targeted-release budesonide formulation, in Japanese adults suffering from primary immunoglobulin A nephropathy. The trial met its primary endpoint, demonstrating a 33.75 percent reduction in urine protein-to-creatinine ratio after nine months of treatment.

The multicenter, open-label study evaluated 39 patients at risk of developing end-stage renal disease, a condition that remains a significant health burden in Japan. Beyond the primary endpoint, participants showed improved estimated glomerular filtration rates and reductions in serum creatinine levels. The data indicated that the drug was well tolerated, with a safety profile consistent with global findings. No study participants required dialysis or kidney transplantation during the trial period.

Philippe Martin, Chief R&D Officer at Viatris, noted that the results position VR-205 as a potential disease-modifying therapy in a country that reports the world's highest incidence of the disease. Following these results, the company plans to submit a New Drug Application to Japanese regulatory authorities by the end of 2026. If approved, the medication would offer a specialized oral treatment for a condition currently lacking curative options.

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