AbbVie's submitted NDA for elagolix for the treatment of heavy menstrual bleeding associated with uterine fibroids in women is supported by the results of 2 phase 3 studies.
A New Drug Application (NDA) has been submitted to the US Food and Drug and Administration (FDA) for AbbVie’s oral gonadotropin-releasing hormone antagonist elagolix (ABT-620) for the management of heavy menstrual bleeding associated with uterine fibroids in women.
AbbVie announced submission of the NDA, which is supported by data from phase 3 studies that enrolled nearly 800 patients, for elagolix early Monday morning.
"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 of AbbVie. "If approved, this combination has the potential to offer women and their healthcare providers an additional oral medical treatment option."
The ELARIS UF-I and ELARIS UF-II phase 2 studies are the studies being used to support the NDA for elagolix. The studies, from AbbVie’s phase 3 uterine fibroid program, evaluated the safety, tolerability, and efficacy of elagolix alone and in combination with low-dose hormone therapy in women with uterine fibroids for 6 months.
ELARIS UF-I found that elagolix in combination with low-dose hormone therapy reduced heavy menstrual bleeding in 68.5% of women with uterine fibroids compared to 8.7% with placebo. Similarly, ELARIS UF-II found that elagolix use reduced heavy menstrual bleeding with 76.2% of women achieving clinical response versus 10.1% seen in the placebo group.
An extension study, that examined treatment over an additional 6 months found that elagolix use reduced heavy menstrual bleeding in 87.9% of women with uterine fibroids.
The primary endpoint of those studies assessed the reduction in heavy menstrual bleeding compared to placebo as measured by the alkaline hematin method. In both studies, investigators found that elagolix — in combination with add back therapy — met the study’s primary endpoint.
The most frequent adverse events reported from the trials were hot flush, night sweats, nausea, headache and fatigue. Elagolix has previous FDA approval for the treatment of endometriosis pain dating back to July 2018.