FDA Approves Drug to Manage Endometriosis PainJuly 25, 2018
The Food and Drug Administration (FDA) has approved Orilissa (elagolix; AbbVie) for the management of moderate to severe pain associated with endometriosis, according to a company news release. Orilissa is an oral gonadotropin-releasing hormone (GnRH) receptor antagonist.
FDA approval is based primarily on 2 randomized placebo-controlled trials. Results of both pivotal trials were published last year in a single report (Taylor et al., 2017).
Endometriosis is a condition in which tissue similar to the lining of the uterus grows in other places in the body. It affects more than 11% of American women between 15 and 44 years of age.
Orilissa will be commercially available in early August 2018.
PR Newswire. AbbVie Receives U.S. FDA Approval of ORILISSA™ (elagolix) for the Management of Moderate to Severe Pain Associated with Endometriosis [news release]. July 24, 2018. Available at: click here. Accessed July 24, 2018.