European Commission approve marketing authorisation application for combination of relugolix 40mg, estradiol 1mg and norethindrone acetate 0.5mg (Ryeqo) for the treatment of uterine fibroids

The approval is based on safety and efficacy data from the Phase 3 LIBERTY program consisting of two replicate, 24-week, multinational clinical studies Liberty 1 & 2, a one-year extension study, and supportive bone mineral density data from a randomized withdrawal study.