The FDA granted priority review to AbbVie’s elagolix, an investigational drug for endometriosis management.
The NDA is based on data from the largest randomized clinical endometriosis trials ever conducted, with nearly 1,700 women evaluated.
Elagolix is an orally administered gonadotropin-releasing hormone antagonist. AbbVie executives said they hope to bring the treatment to market as soon as possible. The company expects the PDUFA date for review completion to be in the second quarter of 2018.