FDA approves AbbVie's Orilissa for endometriosis pain

FDA approved Orilissa elagolix from AbbVie Inc. (NYSE:ABBV) for the management of moderate to severe pain associated with endometriosis. AbbVie expects to launch the drug early next month at a wholesale acquisition cost (WAC) of $844.87 per month, spokesperson Toni Haubert told BioCentury.

Orilissa is a non-peptide small molecule gonadotropin-releasing hormone (GnRH) antagonist. AbbVie said the drug is the first oral treatment approved in more than a decade for the indication. FDA evaluated Orilissa's NDA under Priority Review, although it extended the drug's review by three months to evaluate additional liver function data...