EU approves Yselty for uterine fibroids.- ObsEva
ObsEva announced that the European Commission (EC) has granted marketing authorization for Yselty (linzagolix), an oral GnRH antagonist, for the management of moderate to severe symptoms of uterine fibroids (UF) in adult women (over 18 years of age) of reproductive age.
The EC decision follows confirmation of a positive opinion from the Committee for Medicinal Products for Human Use of the European Medicines Agency in April 2022, and is valid in all 27 European Union Member States, as well as Iceland, Norway, and Liechtenstein.
The approval is based on positive data from the Company’s two Phase III PRIMROSE trials. The pooled week 24 data from these studies support a potentially best-in-class profile, with a responder rate of 84.5% in women receiving linzagolix 200 mg with hormonal ABT, and 56.5% in women receiving linzagolix 100 mg without ABT.
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