OBSV - ObsEva granted European nod for uterine fibroids therapy

Women’s health company ObsEva (NASDAQ:OBSV) announced on Friday that the European Commission (EC) granted marketing authorization for Yselty as a treatment for symptoms related to uterine fibroids (UF) in adult women of reproductive age. According to the company, the drug, also known as linzagolix, is the only approved oral GnRH antagonist to provide flexible dosing options, with and without additional hormonal therapy for UF patients. The EC authorization follows a positive opinion on the drug from the Committee for Medicinal Products for Human Use of the European Medicines Agency (EMA) in April 2022. The decision allows the company to market Yselty in all 27 EU member states as well as Iceland, Norway, and Liechtenstein. Under a partnership with Theramex, ObsEva (OBSV) is entitled to royalties of mid-thirties percentage on commercial sales of Yselty in markets outside the U.S., Canada, and Asia.

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ObsEva granted European nod for uterine fibroids therapy