Results from the Phase 3 ELARIS UF-EXTEND extension study demonstrated that elagolix, in combination with low add-back therapy (estradiol 1mg/norethindrone acetate 0.5mg), reduced heavy menstrual bleeding for up to 12 months in premenopausal women with uterine fibroids.
In this extension study, patients who received elagolix 300mg twice daily or elagolix 300mg twice daily + add-back therapy in the pivotal studies (ELARIS UF-I and ELARIS UF-II) continued to receive the same treatment while those who received placebo in the pivotal studies were randomized to 1 of 2 treatment groups (elagolix 300mg twice daily or elagolix 300mg twice daily + add-back therapy).
Results showed that 87.9% (N=206) of patients who received the combination of elagolix + add-back therapy had a clinical response, defined as menstrual blood loss volume of ≤80mL and a ≥50% reduction in menstrual blood loss volume from baseline to the final month (month 12). The findings from the extension study were consistent with those observed in ELARIS UF-I and ELARIS UF-II, in which 68.5% (N=206) and 76.2% (N=189) of patients who received the combination achieved clinical response.
No new safety signals were identified in the extension study; the safety profile was consistent with what was previously reported from the pivotal studies.
Elagolix (Orilissa; AbbVie) is currently approved by the FDA to treat moderate to severe pain associated with endometriosis. AbbVie plans to submit data from the phase 3 uterine fibroids program to the FDA sometime in 2019.
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