Posted by Michael Wonder on 12 Jan 2021
ObsEva provides update on Yselty (linzagolix) clinical development program
11 January 2021 - European Medicines Agency validates Yselty marketing authorisation application for uterine fibroids; US NDA Planned for 1H 2021.
The Marketing Authorization Application (MAA) is an application for approval submitted to the EMA and is a critical step in marketing a product in the European Union. Validation marks the beginning of the review period.
The Yselty MAA for the uterine fibroids’ indication is based on data from the Phase 3 PRIMROSE 1 trial (conducted in the US, which enrolled 574 women with uterine fibroids) and the PRIMROSE 2 trial (conducted in Europe and the US, which enrolled 535 women with uterine fibroids).
