Myovant Sciences Submits New Drug Application (NDA) to the FDA for Once-Daily Relugolix Combination Tablet for the Treatment of Women with Uterine Fibroids

• NDA is supported by positive data from two Phase 3 studies and a long-term extension study, demonstrating sustained reduction in heavy menstrual bleeding while maintaining bone health through one year
• If approved, relugolix combination tablet would be the first once-daily, oral treatment for women with heavy menstrual bleeding associated with uterine fibroids in the U.S.  

BASEL, Switzerland, June 01, 2020 (GLOBE NEWSWIRE) -- Myovant Sciences (NYSE: MYOV), a healthcare company focused on redefining care for women and for men, today announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for its once-daily relugolix combination tablet (relugolix 40 mg, estradiol 1.0 mg, and norethindrone acetate 0.5 mg) for the treatment of women with heavy menstrual bleeding associated with uterine fibroids.

“An estimated five million women in the U.S. suffer from symptoms of uterine fibroids, which may include heavy menstrual bleeding, pain, and anemia – yet effective non-invasive treatment options are very limited,” said Lynn Seely, M.D., chief executive officer of Myovant Sciences. “If approved, we hope to redefine care for these women with relugolix combination tablet, a potential new treatment that demonstrated a predictable and clinically-meaningful reduction in menstrual blood loss while maintaining bone health in the Phase 3 LIBERTY program.”

The NDA submission in uterine fibroids is supported by positive results from the Phase 3 LIBERTY program, which included two multinational replicate studies and an open-label extension study through one year. The NDA is the third regulatory application Myovant has submitted this year, following a Marketing Authorization Application to the European Medicines Agency in uterine fibroids and an NDA in advanced prostate cancer. Myovant is also advancing the Phase 3 SPIRIT program, evaluating relugolix combination therapy (relugolix 40 mg plus estradiol 1.0 mg and norethindrone acetate 0.5 mg) in women with pain associated with endometriosis, with data from a second Phase 3 study expected this quarter. SPIRIT 2, the first of the two Phase 3 studies of once-daily relugolix combination therapy in women with pain associated with endometriosis, met its co-primary efficacy endpoints and six key secondary endpoints. In addition, relugolix combination therapy was generally well-tolerated including minimal bone mineral density loss over 24 weeks.