FDA accepts NDA for relugolix combo for uterine fibroids

Switzerland-based Myovant Sciences (NYSE: MYOV) says that its New Drug Application (NDA) for once-daily, oral 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 has been accepted for review by the US Food and Drug Administration.

“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 Dr Lynn Seely, chief executive officer of Myovant Sciences, which is majority-owned by Japan’s Sumitomo Dainippon Pharma (TYO: 4506).

“An estimated five million women in the US 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,” Dr Seely noted.