Obseva SA (NASDAQ:OBSV) Reports, Topline Results from Phase 3 Studies of PRIMROSE 1 and 2, of Yselty; a Potential Treatment for Uterine Fibroids

When it comes to menstruation, hundreds of women are suffering silently. A healthy and typical period should last between three to eight days. However, those with fibroids sometimes have heavier and irregular periods. Nonetheless, Obseva SA (NASDAQ:OBSV) is so passionate about improving women’s reproductive health through novel therapies.

The GENEVA, Switzerland based company has been developing a potential treatment option, which it says can take care of up to 50% of US women with uterine fibroids. Results from two phases of three studies of PRIMROSE 1 and 2 of Yselty® (linzagolix) are reportedly very encouraging.

The study was carried for 52 weeks and the candidates have included 535 women with heavy menstrual bleeding. They were given linzagolix doses of 100 mg and 200 mg. At week 24, PRIMROSE 1 had already met the primary endpoint demonstrating its ability to reduce menstrual blood loss in women. By the end of the 52 weeks, PRIMROSE 2 also demonstrated sustained efficacy and tolerance.

Obseva Is Now Preparing Its Regulatory Submissions to EMA and the FDA

Uterine fibroids are a common disorder and more often affect women of childbearing age. They vary in size and sometimes can remain undetectable for a long time and end up becoming a large mass. However, the CEO of Obseva, Ernest Loumaye, says that if the results from the study re anything to go by, then there is hope for women being able to reduce the pain which comes with uterine fibroids. Thanks to Yselty, which is taken once-a-day.

“New and effective treatment options that provide long-lasting symptom relief are needed for women with uterine fibroids…’’ Dr. Hugh Taylor, a professor at Yale School of Medicine, U.S, noted.

Meanwhile, Obseva is ready to take the next step of submission of the results to the European Medicines Agency (EMA) and the FDA. This is likely to happen 4Q 2020 and 1H 2021, respectively. The company says it will take any extra mile required to ensure a woman’s overall health and well-being are taken care of.

For some women forgetting pads or tampons is just a small inconvenience, but those with uterine fibroids could mean canceling of major plans. They have to walk around with a Period Survival Kit.