Posted by Michael Wonder on 05 Aug 2019
AbbVie submits new drug application to US FDA for investigational elagolix for management of heavy menstrual bleeding associated with uterine fibroids in women
5 August 2019 - New drug application is supported by data from pivotal Phase 3 studies of nearly 800 patients.
AbbVie, in cooperation with Neurocrine Biosciences, today announced the submission of a new drug application to the U.S. FDA for elagolix, an investigational, oral gonadotropin-releasing hormone antagonist, for the management of heavy menstrual bleeding (HMB) associated with uterine fibroids in women.
The application is supported by data from the elagolix Phase 3 uterine fibroid program, which evaluated nearly 800 premenopausal women with HMB associated with uterine fibroids in two pivotal studies (ELARIS UF-I and ELARIS UF-II) at approximately 100 sites in the U.S. and Canada.
