News
Positive CHMP opinion for linzagolix, an oral GnRH antagonist, for the treatment of uterine fibroids.
ObsEva SA announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending approval of linzagolix, an oral GnRH antagonist for the management of moderate to severe symptoms of uterine fibroids (UF) in adult women of reproductive age.
ObsEva’s Marketing Authorisation Application submission was based on positive data from the Company’s two Phase III PRIMROSE trials. If approved, linzagolix would be the first and only approved GnRH receptor antagonist with a non-hormonal option to address the needs of women who cannot or do not want to take hormones.
Condition: Uterine Fibroids
Type: drug
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