Posted by Michael Wonder on 10 Mar 2020
Myovant Sciences submits marketing authorisation application to the EMA for relugolix combination tablet for the treatment of women with uterine fibroids
9 March 2020 - New drug application to the U.S. FDA planned for submission in April 2020.
Myovant Sciences today announced the submission of a marketing authorisation application to the EMA for relugolix combination tablet (relugolix 40 mg, oestradiol 1.0 mg, and norethindrone acetate 0.5 mg) for the treatment of women with moderate to severe symptoms associated with uterine fibroids. The two most common symptoms associated with uterine fibroids are heavy menstrual bleeding and pain.
The application is supported by efficacy and safety data from the Phase 3 LIBERTY program which consisted of two multinational, replicate pivotal clinical studies, LIBERTY 1 and 2, as well as data from a one-year open-label extension study of relugolix combination therapy.
