Myovant to Seek Regulatory Approval of Uterine Fibroid Treatment Following Positive Late-Stage Trial

 

More than five million women suffer from symptoms of uterine fibroids, with more than half of them estimated to have received inadequate treatment. However, new data released by Myovant shows that concerns of inadequate treatment could soon change.

This morning, Switzerland-based Myovant announced an 88% one-year response rate in the positive Phase III LIBERTY extension study of once-daily, oral relugolix combination therapy in women with heavy menstrual bleeding associated with uterine fibroids. Additionally, the company said women who received the treatment experienced, on average, an 89.9% reduction in menstrual blood loss from baseline at one year. Additionally, Myovant said bone mineral density was maintained through one year in the women who received the treatment. Those results remained consistent with previous studies, the company said.

Uterine fibroids are noncancerous tumors but they can cause debilitating symptoms, including abnormal uterine bleeding, heavy or painful periods, anemia, abdominal pain, backache, increased abdominal girth and bloating, urinary frequency or retention, constipation or painful defecation, pregnancy loss, painful intercourse and, in some cases, infertility. Ayman Al-Hendy, director of Translational Research, University of Illinois College of Medicine, said there are approximately 250,000 women who undergo hysterectomies each year due to uterine fibroids. Having a non-invasive treatment that provides long-term options for these women would be a “game-changer for physicians and millions of women who suffer from this common condition,” Al-Hendy said in a statement.

In the primary endpoint analysis, Myovant reported that 87.7% of women achieved the responder criteria defined as a menstrual blood loss volume of less than 80 mL and a 50% or greater reduction from baseline in menstrual blood loss volume during the last 35 days of treatment. The safety data for relugolix remained consistent with previous studies, the company said. Complete results from the LIBERTY open-label extension study will be submitted for presentation at a future scientific meeting and publication in a medical journal.

Based on the results, Myovant expects to submit a New Drug Application to the U.S. Food and Drug Administration in April 2020. The company also plans to submit the data for regulatory approval in Europe as well.

Relugolix is a once-daily, oral gonadotropin-releasing hormone (GnRH) receptor antagonist that reduces ovarian estradiol production. Ovarian estradiol is a hormone known to stimulate the growth of uterine fibroids and endometriosis. Myovant is developing a relugolix combination tablet for women with heavy menstrual bleeding with associated uterine fibroids and for women with pain associated with endometriosis.

Lynn Seely, chief executive officer of Myovant, said the company is pleased the one-year safety and efficacy data for the relugolix combination therapy remain consistent with the company’s data demonstrating a “predictable and clinically-meaningful reduction in menstrual blood loss while maintaining bone health.”

“We look forward to submitting applications to the regulatory agencies in Europe and the U.S. in the coming months to seek approval for our one pill, a once-a-day potential new treatment for women with uterine fibroids,” Seely said in a statement.