Myovant Sciences has submitted an NDA to the FDA for its once-daily relugolix for the treatment of women with heavy menstrual bleeding associated with uterine fibroids.

Myovant Sciences announced that it has submitted a New Drug Application (NDA) to the 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.

The NDA submission in uterine fibroids is supported by positive results from the Phase III 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 III 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 III study expected this quarter. SPIRIT 2, the first of the two Phase III 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.