Based on its success in a Phase 2b study, AbbVie (ABBV) intends to proceed to Phase 3 development for Elagolix, an inhibitor of gonadotropin releasing hormone (GnPH) receptors in the pituitary gland, for the treatment of women with heavy menstrual bleeding (HMB) associated with uterine fibroids. The trial should commence in Q1 and will have the same primary efficacy endpoint as the 2b study.
The Phase 2b trial, M12-813, was a 24-week, randomized, double-blind, placebo-controlled study in 567 premenopausal women with HMB associated with uterine fibroids. It evaluated two different Elagolix treatment regimens (300 mg twice daily, 600 mg once daily) alone and in combination with two different strengths of add-back therapy (estradiol/norethindrone acetate). Preliminary results showed that all Elagolix arms, with or without add-back therapy, experienced reduced HMB compared to placebo (p<0.001). The primary endpoint was a composite design where participants had to achieve a menstrual blood loss (MBL) volume of less than 80 mL and at least a 50% reduction in MBL from baseline at the final study month.
AbbVie licensed Elagolix, also in development for endometriosis, from Neurocrine Biosciences (NBIX +0.9%) in 2010.
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