Following the successful and positive data from phase 3 trials for Yselty (linzagolix), Obseva has received approval from the European commission to commercialise the drug in the EU. Yselty is an Oral GnRH Antagonist for the treatment of uterine fibroids in adult women. Theramex will commercialise the drug. ObsEva will receive royalties on commercial sales, as well as development, commercial, and sales-based milestone payments.
The European Commission 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.
ObsEva's Yselty is the only approved oral GnRH antagonist to offer flexible dosing options, with and without additional hormonal therapy, for women (over 18 years of age) suffering from UF. For women with UF for whom hormonal add-back therapy (ABT, estradiol 1 mg and norethisterone acetate 0.5 mg) is appropriate, Yselty offers a potentially best-in-class efficacy rate and favourable tolerability profile. For women with UF who cannot or do not want to take hormones, Yselty is the first and only approved oral GnRH antagonist with a non-hormonal dosing option.
The approval is 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.
Brian O’Callaghan, CEO of ObsEva, commented, “Our first approval marks a major milestone for ObsEva and further validates our work to address one of the most challenging unmet needs facing women. As we transition to a commercial stage company, our agreement with Theramex provides a strong foundation to realize the potential for linzagolix across key markets, and we look forward to commercial launch in Europe.”
Strategic partnership with Theramex
In February 2022, ObsEva entered into a strategic licensing agreement with Theramex, a global leader in women’s health, to support the commercialization and market introduction of linzagolix across international markets outside of the U.S., Canada, and Asia. Under 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 EUR72.75 million in upfront and milestone payments, including up to EUR13.75 million in development and commercial milestones and up to EUR54 million in sales-based milestones.
The NDA for linzagolix in the U.S. is currently under review by the FDA, with a PDUFA target action date of September 13, 2022.
About Uterine Fibroids
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. Few long-term medical treatments are available, and as a result, approximately 300,000 hysterectomies are performed for uterine fibroids every year in the United States.
The symptoms of uterine fibroids are wide-ranging and include heavy menstrual bleeding, anaemia, pelvic pressure and bloating, urinary frequency and pain that can be extremely debilitating with a significant impact on quality of life. These symptoms can also have an impact on mental health, creating the additional burden of anxiety and distress.
(Press release)
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