AbbVie has announced positive outcomes from the second of two pivotal Phase 3 studies (ELARIS UF-II) of elagolix in combination with low-dose hormone (add-back) therapy (estradiol 1.0mg/norethindrone acetate 0.5mg) for the treatment of premenopausal women with uterine fibroids. The trial met its primary endpoint of clinical response defined as menstrual blood loss <80mL during month 6 and a ≥50% reduction in menstrual bleeding loss volume from baseline to 6 months.
Results – measured by the alkaline hematin method – found that at 6 months, 76.2% (P<0.001) of patients in the combination group acheived clinical response compared to 10.1% for placebo. In addition, overall safety data has been consistent with the results from previous trials.
Elagolix, an oral gonadotropin-releasing hormone (GnRH) antagonist, works through reversible, dose-dependent inhibition of luteinizing hormone (LH) and follicle-stimulating hormone (FSH) secretion, leading to decreased ovarian production of estradiol and progesterone.
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