NEW YORK and LONDON: Sumitovant Biopharma Ltd. has said that Myovant Sciences, one of five healthcare companies in the Sumitovant family of companies, 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. This comes on the heals of positive results from the Phase 3 LIBERTY program, which included two multinational replicate studies and an open-label extension study through one year.
Lynn Seely, M.D., CEO, Myovant Sciences said,”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 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.
Relugolix is a once-daily, oral gonadotropin-releasing hormone (GnRH) receptor antagonist that reduces ovarian estradiol production, a hormone known to stimulate the growth of uterine fibroids and endometriosis, and testicular testosterone production, a hormone known to stimulate the growth of prostate cancer.