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Yselty – Uterine Fibroids

June 23, 2022

Yselty® (lingaolix) is approved in the EU for the management of moderate to severe symptoms of uterine fibroids in adult women (over 18 years of age) of reproductive age.

Yselty® is the first and only approved oral GnRH antagonist to offer flexible dosing options, with and without additional hormonal therapy, for women 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 1,2,3 and favorable 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.

Yselty® is approved at the following doses:

  • 100 mg or 200 mg once daily with hormonal ABT, with no limitation in treatment duration
  • 100 mg once daily for women in whom ABT is not recommended or who prefer to avoid hormonal therapy, with no limitation in treatment duration
  • 200 mg once daily for short-term use (< 6 months) in clinical situations when reduction of uterine and fibroid volume is desired

The EC decision 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 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. Few long-term medical treatments are available.

The symptoms of uterine fibroids are wide-ranging and include heavy menstrual bleeding, anemia, 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.

The European Commission granted marketing authorization for Yselty® in June 2022.

1. Stewart E, ASRM 2020; Late-breaker abstract P-930
2. Al-Hendy A, NEJM 2021; 384:630-42
3. Schlaff W, NEJM 2020; 382:328-40

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Note that the following information contains information on investigational medicinal products. These products have not yet been approved for marketing by the European Medicines Agency or the U.S. Food and Drug Administration and are still under development. Further additional investigations may be needed in order for the marketing authorization to be granted, which grant may depend on a variety of factors and is not guaranteed. Click on “return” if you do not wish to receive such information. By clicking on “continue” you acknowledge that you wish to receive scientific information on our investigational products.

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Disclaimer

Note that the following information contains information on investigational medicinal products. These products have not yet been approved for marketing by the European Medicines Agency or the U.S. Food and Drug Administration and are still under development. Further additional investigations may be needed in order for the marketing authorization to be granted, which grant may depend on a variety of factors and is not guaranteed. Click on “return” if you do not wish to receive such information. By clicking on “continue” you acknowledge that you wish to receive scientific information on our investigational products.

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