A New Drug Application for elagolix for the management of heavy menstrual bleeding associated with uterine fibroids has been submitted to the Food and Drug Administration by AbbVie.
The NDA is supported by data from two phase 3 studies, ELARIS UF-1 (N=412) and ELARIS UF-2 (N=378) which evaluated the efficacy, safety, and tolerability of elagolix, an oral gonadotropin-releasing hormone (GnRH) antagonist, alone and in combination with estradiol/norethindrone acetate (add-back therapy) for the management of heavy menstrual bleeding associated with uterine fibroids in premenopausal women.
Results from these studies showed that 68.5% and 76.2% of women achieved clinical response when treated with elagolix plus add-back therapy compared with placebo in ELARIS UF-1 and ELARIS UF-2, respectively; clinical response was defined as menstrual blood loss volume of less than 80mL during final month and a 50% or greater reduction in menstrual blood loss volume from baseline to final month.
In addition, results from an extension study (ELARIS UF-EXTEND) showed that the combination therapy reduced heavy menstrual bleeding for up to 12 months; 87.9% (n=206) of patients who received elagolix + add-back therapy had a clinical response.
With regard to safety, the most frequently reported adverse reactions included hot flush, night sweats, nausea, headache, and fatigue.
“This submission brings us closer to our goal of improving care for women who continue to struggle with the often disruptive effects of uterine fibroids,” said Michael Severino, MD, vice chairman and president, AbbVie. “If approved, this combination has the potential to offer women and their healthcare providers an additional oral medical treatment option.”
Elagolix (Orilissa; AbbVie) is currently approved to treat moderate to severe pain associated with endometriosis.
For more information visit abbvie.com.