AbbVie Announces Positive Topline Results from Phase 3 ELARIS UF-EXTEND Study of Elagolix in Women with Uterine Fibroids

By Cathy Burke

August 22,AbbVieWith CollaboratorsNeurocrine BiosciencesAnnounced Phase 3 Clinical TrialELARIS UF-EXTEND Extension Study(MI2-816) data. The results showed that at month 12, the drugelagolix(300 mg, twice daily) with low-doseHormone Therapy(Estradiol 1.0 mg/norethindrone acetate 0.5 mg) combination,Reduced by 87.9% in patients with uterine leiomyomasHeavy Menstrual Bleeding。

This result is consistent with two pivotal Phase 3 clinical studies (ELARIS UF-I, ELARIS UF-II）consistent with the results observed in. In two key studies,68.5% and 76.2% of patients with uterine fibroids receiving elagolix add-back therapy achieved clinical remission after 6 months of treatment. (In this study, clinical remission was defined as menstrual blood loss of less than 80 mL and a reduction of 50% or greater in menstrual blood loss from baseline to the last month.)）Expanded Study (ELARIS UF-EXTEND) The results of the secondary endpoints were also consistent with those observed in the pivotal studies.

Two pivotal studies evaluated the safety and efficacy of elagolix alone and in combination with add-back therapy for up to 6 months in patients with uterine fibroids and heavy menstrual bleeding. Expanded studyThis is a Phase 3, randomized, double-blind, multicenter, extension study designed to evaluate the safety and efficacy of elagolix alone and in combination with add-back therapy for up to 12 months in patients with uterine fibroids and heavy menstrual bleeding. Patients will receive either elagolix alone or elagolix in combination with add-back therapy, while subjects who received placebo in the pivotal study will be randomized into one of the two treatment groups.

The results of the Phase 3 clinical study are as follows:

The safety information from the ELARIS UF-EXTEND study was consistent with the previously reported topline results from the pivotal Phase 3 clinical trials, and no new safety signals were identified. The most common adverse reactions (≥5%) were hot flushes, night sweats, nausea, headache, and nasopharyngitis; additionally,Decreased Bone Mineral Density (BMD). Assessment of BMD at 12 months showed,Compared with women receiving elagolix monotherapy,The mean change in BMD from baseline was smaller in women with uterine fibroids and heavy menstrual bleeding who received elagolix combined with add-back therapy.

Data from the pivotal Phase 3 clinical study will be presented at medical conferences later this year, while data from the ELARIS UF-EXTEND study will be presented at future medical conferences. Elagolix is planned for marketing application in 2019.

Elagolix is aOral Gonadotropin-Releasing Hormone (GnRH) Antagonistby inhibiting the gonadotropin-releasing hormone receptors in the pituitary gland, ultimately reducing the levels of gonadal hormones in the bloodstream. Currently, this drug is being studied for the treatment of diseases mediated by ovarian sex hormones, such as uterine fibroids and endometriosis.

Elagolix Molecular Structure (from Wikipedia)

Uterine FibroidsThey are the most common type of abnormal benign cystic growths in the female pelvis. Most women in the United States will develop fibroids during their lifetime. Fibroids can be asymptomatic, but approximately 25% of women experience symptoms such as menorrhagia, dysmenorrhea, abnormal uterine bleeding, and anemia. African American women are more susceptible to fibroids and tend to develop them at a younger age.

Dawn Carlson, Vice President of Generic Drug Development at AbbVie, stated, “Women with uterine fibroids need additional medical management options to help address unresolved symptoms. The results of this extension study provide useful information on the 12-month continuous treatment with elagolix in patients with uterine fibroids and heavy menstrual bleeding.”(Sina Medicine compiled by David)

Sources:https://news.abbvie.com/news/abbvie-announces-positive-topline-results-from-phase-3-extension-study-evaluating-investigational-elagolix-in-women-with-uterine-fibroids.htm