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AbbVie files for US FDA approval of elagolix in uterine fibroids

AbbVie Inc. has filed for U.S. Food and Drug Administration approval of its women's health drug elagolix to treat heavy menstrual bleeding in women with uterine fibroids.

Elagolix, also known as Orilissa, is an oral gonadotropin-releasing hormone, or GnRH, antagonist developed by North Chicago, Ill.-based AbbVie. Uterine fibroids are noncancerous muscle tissue tumors that develop in a woman's uterus. As many as 70% of white women and 80% of black women will be affected by fibroids by age 50. While fibroids can be asymptomatic, some women experience heavy menstrual bleeding outside of their usual menstruation and anemia.

The drug was submitted to the U.S. regulator based on data from a phase 3 clinical trial program that featured 800 premenopausal women with uterine fibroids. Heavy bleeding was reduced in the women taking elagolix.

AbbVie is racing to market with elagolix against a number of similar products under development. Myovant Sciences Ltd. in July announced that the company's similar treatment, relugolix, reduced heavy menstrual bleeding in women with a single-pill treatment regimen. ObsEva SA also has a GnRH antagonist called linzagolix underway for uterine fibroids.

Elagolix is already approved to treat endometriosis and is being studied in polycystic ovary syndrome, which causes infrequent or prolonged menstrual periods.

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