OBSV - FDA accepts for review Obseva's linzagolix application for uterine fibroids

Obseva (NASDAQ:OBSV) announces that the New Drug Application (NDA) for linzagolix for the management of heavy menstrual bleeding associated with uterine fibroids in premenopausal women has been accepted for review by the U.S. FDA. The submission is based on data from the two Phase 3 PRIMROSE trials. The FDA has set a target action date of September 13, 2022 for this NDA under PDUFA. Linzagolix has a differentiated profile and if approved, would be the first and only GnRH receptor antagonist with flexible dosing options for uterine fibroids, including a low dose option to address the needs of women who cannot or do not want to take hormones. Last month, Obseva inked partnership with Syneos Health to support commercialization of linzagolix in U.S. and EU. OBSV submitted linzagolix NDA in U.S. for uterine fibroids in September 2021.

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FDA accepts for review Obseva's linzagolix application for uterine fibroids