“Gwyn Lo will provide a discreet option for women seeking a reversible, non-invasive, once-weekly contraception patch with a low dose of estrogen,” said Philippe Martin, Viatris Chief R&D Officer. “Building on our expertise in transdermal drug delivery systems and legacy in women’s health, we are pleased that the approved label for this new patch reflects the strength of our clinical program. This includes demonstrated efficacy in women with a BMI of 25 to less than 30 kg/m², with no BMI-based limitation of use in this population.”

The approval was granted under the FDA’s 505(b)(2) regulatory pathway and was supported by results from the Phase 3 Luminous Study (NCT05139121), which demonstrated contraceptive efficacy, a well-characterized safety profile and robust patch adhesion performance.