AbbVie Inc (NYSE:ABBV) reported that the Phase III ELARIS UF-II trial of elagolix met its main endpoint. Data from the second of two major Phase III trials showcased at month six that elagolix, together with low-dose hormone therapy, lowered heavy menstrual bleeding with 76.2% of females with uterine fibroids recording clinical response versus placebo, as computed by the alkaline hematin process. The trial also fulfilled all ranked secondary objectives at month six.
Uterine fibroids marks as the most prevalent kind of abnormal growth in a female’s pelvis and can impact up to 80% of women by age of 50 years. Fibroids can be asymptomatic, however in around 25% of women, fibroids can cause indications, such as vaginal bleeding, painful periods, heavy menstrual bleeding, at times other than anemia and menstruation. African American women are increasingly prone to suffer from fibroids and get so at a younger age.
Dawn Carlson, M.D., M.P.H., the VP at General Medicine Development, expressed that millions of females presently diagnosed with uterine fibroids are met with limited non-surgical choices. The data from this trial showcase elagolix has the prospect to be a vital oral treatment alternative for female suffering from uterine fibroids.
Hypoestrogenic effects from elagolix treatment were noted in the trial. The overall safety profile was consistent with what was noted in Phase II trials and the first Phase III trial in uterine fibroids. Report from the ELARIS UF-II Phase III trial will support regulatory filings for elagolix. Safety report continue to be gathered in this ongoing trial.
The topline data from this six-month initial review were consistent with topline data from the ELARIS UF-I trial posted in February 2018. This topline report will be showcased at an imminent medical conference. Females in the trial will continue in either a blinded six-month extension or post-treatment follow-up trial.