Sumitovant Biopharma Ltd announced on Tuesday that Myovant Sciences (NYSE: MYOV), one of five healthcare companies in the Sumitovant family of companies, has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for its once-daily relugolix combination tablet (relugolix 40mg, estradiol 1.0mg, and norethindrone acetate 0.5mg) for the treatment of women with heavy menstrual bleeding associated with uterine fibroids.

'An estimated five million women in the US suffer from symptoms of uterine fibroids, which may include heavy menstrual bleeding, pain, and anaemia - yet effective non-invasive treatment options are very limited,' said Lynn Seely, MD, CFO 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 in women with pain associated with endometriosis, with data from a second Phase 3 study expected this quarter.