- Topline six-month results of AbbVie Inc.'s Phase 3 study of elagolix show the drug, in combination with low dose estradiol/norethindrone acetate (add-back therapy), cuts heavy menstrual bleeding in women with uterine fibroids. The North Chicago-based company is working with Neurocrine Biosciences Inc. on the treatment.
- Over 68% of women given the drug met the study's primary endpoint, compared with fewer than 9% of those on placebo. Side effects included hot flashes and drops in bone mineral density.
- AbbVie will use the ELARIS UF-I data, the first of two pivotal trials, to support its regulatory submissions, and women in the study will have either post-treatment follow-up or enter a blinded, six-month extension study.
Up to 80% of women develop uterine fibroids by the age of 50, and in a quarter of these, the fibroids cause heavy and painful periods, vaginal bleeding at times other than menstruation, infertility, anemia and other symptoms. Fibroids affect disproportionate numbers of African American women, and at a younger age.
"Current non-surgical treatments are limited and women suffering from uterine fibroids need more therapeutic options," Dawn Carlson, vice president in general medicine development at AbbVie, said in a Wednesday statement.
Elagolix, an oral gonadotropin-releasing hormone receptor antagonist, is pending approval in endometriosis, a painful and common condition in women with few treatment options. The approval application has a Prescription Drug User Fee Act date in April 2018. Analysts predict sales of over $1 billion for this drug by 2022, giving it blockbuster status.
Last October, the Food and Drug Administration accepted Allergan plc's new drug application for ulipristal acetate for the treatment of abnormal uterine bleeding in women with uterine fibroids. Allergan expects a PDUFA data in the first half of 2018. The drugmaker also has the troubled Proellex (telapristone acetate) in its pipeline, after its acquisition of Repros Therapeutics Inc. The oral form of Proellex reached Phase 2 for uterine fibroids but has been on partial clinical hold for nearly a decade. Repros considered shifting its focus to the vaginally-delivered version before its acquisition.
Other companies are looking at uterine fibroids as an add-on indication. Astellas Pharma Inc. is carrying out Phase 2 trials with fezolinetant for hot flashes, but it also has potential in uterine fibroids. Enteris BioPharma Inc. is developing an oral leuprolide formulation, Ovarest, for endometriosis in Phase 2a, with Phase 2b trials scheduled for 2018. Future plans include development in uterine fibroid tumors and prostate cancer.