Viatris has announced that the US Food and Drug Administration (FDA) has approved Gwyn Lo (norelgestromin and ethinyl estradiol transdermal system). Gwyn Lo is a new Combined Hormonal Contraceptive (CHC) patch with low-dose estrogen. The patch has demonstrated contraceptive efficacy for women of childbearing potential with a Body Mass Index (BMI) below 30 kg/m² who are appropriate candidates for CHC. The Gwyn Lo dosage is norelgestromin 220 mcg/day and ethinyl estradiol 20 mcg/day.

Philippe Martin, Chief R&D Officer, Viatris, said, "Gwyn Lo will provide a discreet option for women seeking a reversible, non-invasive, once-weekly contraception patch with a low dose of estrogen. 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-characterised safety profile and robust patch adhesion performance.

Data from 4 phase 1 studies investigating various application sites and conditions demonstrated consistent drug delivery under conditions including sauna, whirlpool, treadmill exercise and cold-water bath.

Unintended pregnancy remains a significant public health issue in the US, accounting for 41.6 percent of pregnancies in 2019. Women's contraceptive needs and preferences also vary: in a 2023 CDC survey, 18.1 percent of women who had used a contraceptive method changed or stopped a method within the previous 12 months. Among those women, 42.8 percent reported that they did not like the method they had been using. These findings underscore the continued need for a range of contraceptive options that can align with individual needs and preferences. Gwyn Lo helps address this need by offering a non-invasive, reversible, low-estrogen-dose CHC option for women who prefer once-weekly administration.

The company expects Gwyn Lo to be commercially available later this year and will provide additional information during its upcoming financial results call.