NDA for once-daily, oral relugolix combination tablet for the treatment of women with heavy menstrual bleeding associated with uterine fibroids accepted for review by the FDA.- Myovant Sciences

Myovant Sciences announced that its New Drug Application (NDA) for once-daily, oral 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 has been accepted for review by the FDA. “Relugolix is now under FDA review for two distinct potential new treatment options in uterine fibroids and advanced prostate cancer, indications with high unmet need where we have the opportunity to elevate the standard of care for women and for men,” said Lynn Seely, M.D., chief executive officer of Myovant Sciences. “An estimated five million women in the U.S. suffer from symptomatic uterine fibroids, which may include heavy menstrual bleeding, pain, and anemia. Non-invasive treatment options are limited, and we believe women deserve an alternative to surgery that delivers a predictable and clinically-meaningful reduction in menstrual blood loss while maintaining bone health as demonstrated by relugolix combination therapy in the LIBERTY program.” The FDA has set a target action date of June 1, 2021 under the Prescription Drug User Fee Act (PDUFA). In its acceptance letter, the FDA also stated that it is currently not planning to hold an advisory committee meeting for this application. Relugolix (120 mg) is under Priority Review by the FDA for the treatment of men with advanced prostate cancer, with a target action date of December 20, 2020. Additionally, Myovant submitted a Marketing Authorization Application to the European Medicines Agency in March 2020 for relugolix combination tablet for the treatment of women with uterine fibroids. Myovant has also reported positive data from two replicate Phase III studies evaluating relugolix combination therapy in women with endometriosis.