Phase III LIBERTY study of TAK 385 shows positive results for uterine fibroids.- Myovant Sciences
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Myovant Sciences announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a positive opinion recommending the approval of Ryeqo (relugolix 40 mg, estradiol 1.0 mg, and norethindrone acetate 0.5 mg) for the treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age.
Sumitovant Biopharma announced that the New England Journal of Medicine published Myovant Sciences’ Phase III LIBERTY 1 and LIBERTY 2 studies of investigational once-daily Orgovyx (relugolix combination therapy) (relugolix 40 mg plus estradiol 1.0 mg and norethindrone acetate 0.5 mg) in women with uterine fibroids.
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.