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Reproductive Health & Pregnancy Therapeutics

Uterine Fibroids (UF)

Uterine fibroids are common non-cancerous tumors that grow within the muscular wall of the uterus. They can vary in size and number and when symptomatic, are most often accompanied by heavy menstrual bleeding (HMB), anemia, abdominal pressure and pain, bloating, increased urinary frequency and reproductive dysfunction. Uterine fibroids are associated with an increased risk of pregnancy complications such as infertility, miscarriage, placental abruption, and early onset of labor. According to a study published in the American Journal of Obstetrics & Gynecology in 2003, uterine fibroids affect an estimated 20 to 40 percent of women over the age of 30 in the United States based on clinical cases and women who undergo treatment.

For the millions of women with symptomatic uterine fibroids seeking treatment options, selection is driven by symptom severity, the woman’s age, and her desire to have children now or in the future. While medical, surgical and minimally invasive treatments are available, the standard of care for symptomatic uterine fibroids is a hysterectomy or, in women who wish to preserve their fertility, surgical removal of the fibroid(s).

Linzagolix: An Advancement in the Treatment of Uterine Fibroids

ObsEva is currently advancing Linzagolix, a novel, orally administered GnRH receptor antagonist with a potentially best-in-class profile in late-stage clinical development for the treatment of heavy menstrual bleeding associated with uterine fibroids. Linzagolix acts by binding to and blocking the GnRH receptor in the pituitary gland, ultimately dose-dependently, reducing estrogen production by the ovaries. Through previously reported results from linzagolix and sophisticated pharmacological modelling, it has been established that maintaining estradiol within a specific target range provides the optimal balance between reducing symptoms while mitigating bone density loss associated with excessive estradiol suppression.

Linzagolix – Uterine Fibroids

(OBE2109)
Oral GnRH
receptor antagonist

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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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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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