#United States #FDA Approval #Pittsburgh #Viatris #Gwyn Lo

Viatris Receives FDA Approval for Gwyn Lo™

Viatris Inc., a global leader in healthcare innovation, celebrated a significant milestone as the U.S. Food and Drug Administration (FDA) officially approved their new contraceptive patch, Gwyn Lo™. This once-weekly patch is designed for women of childbearing age with a body mass index (BMI) under 30 kg/m² and aims to provide a non-invasive, reversible contraception option with a low dose of estrogen.

Gwyn Lo combines two active ingredients: norelgestromin and ethinyl estradiol, delivering controlled dosage of 220 mcg and 20 mcg per day, respectively. This innovative patch is utilized over a week for three weeks followed by a patch-free week, offering a convenient option for women looking for effective contraceptive solutions. Philippe Martin, Chief Research and Development Officer at Viatris, expressed excitement about providing a discreet option for women, enhancing their choices in family planning.

The approving process was conducted via the FDA's 505(b)(2) pathway, which allowed Viatris to demonstrate the patch’s efficacy through the Phase 3 Luminous Study (NCT05139121). This clinical study highlighted the patch's effectiveness, reporting a Pearl Index of 4.14, which denotes several pregnancies that occurred during the trial, representing substantial contraceptive success among the evaluated population aged 18 to 35 years.

Moreover, the study reported robust adhesion of the patch during everyday activities; only 1.3% of the 39,790 patches used detached completely over the course of the trial. Participants also noted a decrease in intercycle bleeding and improvements in cycle control over time, validating the patch’s reliability and user-friendly nature.

Reflecting on the issue of unintended pregnancy in the United States, which accounted for nearly 41.6% of all pregnancies in 2019, the findings from the CDC reveal a diverse range of women's preferences when it comes to contraceptive methods. A significant percentage of women (42.8%) switched or stopped using a previous method because they were unsatisfied with it, highlighting the urgent need for flexible and personalized contraceptive options. Gwyn Lo aims to bridge this gap by providing a non-invasive and low-dose solution that fits various lifestyles and preferences.

As Viatris prepares for the commercial release later this year, this patch represents a remarkable addition to the women’s health landscape, alongside their commitment to addressing unmet needs. The company plans to share more information on Gwyn Lo during their upcoming financial results announcement.

About Gwyn Lo

Gwyn Lo is more than just a patch; it symbolizes a shift towards more tailored healthcare solutions for women. It offers a flexible usage approach with the added benefit of a lower estrogen dose, ideally suited for women who prioritize convenience and discretion in their contraceptive choices.

As a multilayer matrix type transdermal system, Gwyn Lo’s innovative design ensures steady delivery of the active ingredients over week-long intervals. The flexible backing layer provides structure to the patch, while a protective liner preserves the active ingredients until application.

Important Safety Information

While Gwyn Lo offers numerous benefits, it is contraindicated for women over the age of 35 who smoke due to heightened risks of cardiovascular events. Additionally, users with a BMI of 30 or above should also avoid this product to mitigate potential complications. Prospective users are advised to consult healthcare providers to ensure this patch suits their medical history and individual risk factors.

As Viatris steps into this new chapter with Gwyn Lo, their mission to empower healthier lives for women continues to take precedence, making strides in women's reproductive health and contraception solutions.