ObsEva : European Commission Approves Yselty To Treat Uterine Fibroids

(RTTNews) - ObsEva SA (OBSV) said Friday that the European Commission has granted marketing authorization for Yselty (linzagolix), an oral GnRH antagonist, for the management of moderate to severe symptoms of uterine fibroids in adult women (over 18 years of age) of reproductive age.

The approval was based on positive data from the company's two Phase 3 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.

Uterine fibroids are common benign tumors of the muscular tissue of the uterus which affect women of childbearing age and can vary in size from undetectable to large bulky masses.

Yselty (linzagolix) is the first and only approved GnRH antagonist to provide flexible dosing options with and without hormonal add-back therapy.

In the United States, the New Drug Application for linzagolix is currently under review by the Food and Drug Administration, with a Prescription Drug User Fee Act or PDUFA target action date of September 13, 2022.

In February 2022, ObsEva entered into a strategic licensing agreement with Theramex to support the commercialization and market introduction of linzagolix across international markets outside of the U.S., Canada, and Asia.

As per the terms of the agreement, ObsEva is entitled to receive royalties of a mid-thirties percentage on commercial sales, which includes the cost of goods sold to Theramex. Furthermore, the agreement contains up to 72.75 million euros in upfront and milestone payments.