ObsEva SA (NASDAQ: OBSV) has disclosed today that it has submitted the Marketing Authorization Application (MAA) to the European Medicines Agency (EMA). The firm has submitted the application for YSELTY for the treatment of uterine fibroids. ObsEva is anticipating to launch the YSELTY in the market after successfully submitting the MAA.
The biotechnology firm is striving to provide a more suitable remedy for the various group of women enduring uterine fibroids. The Phase III trial in uterine fibroids consists of two main trials, PROMISE 1 and PROMISE 2. MAA is presented to EMA after experiencing encouraging results from the Phase III trial. EMA will update the firm about the validation of MAA in December 2020.