Posted by Michael Wonder on 02 Jun 2020
Sumitovant Biopharma announces Myovant Sciences' submission of new drug application to the FDA for once daily relugolix combination tablet for the treatment of women with uterine fibroids
1 June 2020 - Sumitovant Biopharma announced today that Myovant Sciences has submitted a new drug application to the U.S. 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 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.
