24 July 2018 - FDA approval is supported by the largest endometriosis Phase 3 study program conducted to date.
AbbVie announced that the U.S. FDA approved Orilissa (elagolix), the first and only oral gonadotropin-releasing hormone antagonist specifically developed for women with moderate to severe endometriosis pain. The FDA approved Orilissa under priority review.
Orilissa represents the first FDA approved oral treatment for the management of moderate to severe pain associated with endometriosis in over a decade and is expected to be available in U.S. retail pharmacies in early August 2018.