ObsEva Submits MAA To EMA For YSELTY For Treatment Of Women With Uterine Fibroids

(RTTNews) - ObsEva SA (OBSV) said that it has submitted a marketing authorization application to the European Medicines Agency or EMA for YSELTY or linzagolix 100mg and linzagolix 200mg for the management of heavy menstrual bleeding associated with uterine fibroids.

ObsEva expects that the EMA will notify the company in December 2020 regarding the outcome of its validation of the MAA to ensure all essential regulatory elements required for a scientific assessment are included in the application prior to the start of the procedure.

ObsEva expects to submit a new drug application to U.S. Food and Drug Administration in the first-half of 2021.