News & Events zu Viatris Inc (VTRS)VTRSViatris Inc

Viatris Receives FDA Approval for New Contraceptive Patch Gwyn Lo

Viatris announced that the FDA has approved Gwyn Lo, a new combined hormonal contraceptive patch with low-dose estrogen. The patch has demonstrated contraceptive efficacy for women of childbearing potential with a body mass index below 30 kg/m2 who are appropriate candidates for combined hormonal contraception. The Gwyn Lo dosage is norelgestromin 220 mcg per day and ethinyl estradiol 20 mcg per day. The approval was granted under the FDA's 505(b)(2) regulatory pathway and was supported by results from the Phase 3 Luminous Study, which demonstrated contraceptive efficacy, a well-characterized safety profile and robust patch adhesion performance. The primary efficacy endpoint was the Pearl Index of 4.14, defined as the number of pregnancies per 100 woman-years of exposure in the efficacy evaluable population. The study demonstrated patch adhesion under real-world conditions, with only 1.3% of the 39,790 transdermal systems applied during the year-long trial fully detaching. The company expects Gwyn Lo to be commercially available later this year and will provide additional information during its upcoming financial results call.

Viatris Reports Significant Results from VR-205 Clinical Trial

Viatris announced top-line results from a Phase 3 clinical trial evaluating the efficacy and safety of VR-205 in Japanese adult patients with primary immunoglobulin A nephropathy at risk of developing end-stage renal disease. The Phase 3 clinical trial was a multicenter, interventional, open-label study designed to evaluate the efficacy and safety of 16 mg of VR-205 in Japanese adult patients with primary IgAN. Patients were treated for nine months, followed by a three-month follow-up period. The study achieved its primary endpoint, with VR-205 demonstrating a 33.75% reduction in geometric mean urine protein-to-creatinine ratio at nine months compared to baseline. These results were statistically significant and clinically meaningful, and were consistent with those observed in the global Phase 3 program for the product. In addition to a statistically significant and clinically meaningful reduction in UPCR at 6 and 12 months, VR-205 demonstrated a significant improvement in estimated glomerular filtration rate and reductions in serum creatinine and urine albumin-to-creatinine ratio at 9 months compared to baseline. The overall therapeutic benefit of VR-205 was further supported by improvements in microhematuria and a sustained proteinuria reduction. No study participants progressed to dialysis, kidney transplant or severe renal impairment by the end of the study. VR-205 was generally well tolerated over the nine-month treatment period, with a safety profile consistent with the known safety profile of targeted-release budesonide in non-Japanese patients. Viatris is targeting submission of a new drug application in Japan by the end of 2026. In 2022, Calliditas Therapeutics and Viatris Pharmaceuticals Japan Inc., a subsidiary of Viatris entered into an exclusive license agreement to obtain marketing authorization and to commercialize VR-205 for the treatment of primary IgAN in Japan. It is currently a specialty drug approved and marketed as Tarpeyo in the U.S. and as Kinpeygo in Europe.

Viatris MR-107A-02 New Drug Application Accepted by FDA

Viatris announced that the U.S. FDA has accepted for review the New Drug Application for MR-107A-02, a non-opioid, for the treatment of moderate-to-severe acute pain. The FDA has assigned a PDUFA goal date of Dec. 27, 2026.