AbbVie (NYSE:ABBV) has filed a marketing application with the FDA seeking approval of Orilissa (elagolix) for the management of heavy menstrual bleeding associated with uterine fibroids.
Small molecule elagolix inhibits gonadotropin-releasing hormone (GnRH) signaling by binding to GnRH receptors in the pituitary gland. GnRH plays a key role in ovulation and the menstrual cycle.
The FDA approved Orilissa a year ago for the management of endometriosis-associated pain.
The company in-licensed elagolix from Neurocrine Biosciences (NASDAQ:NBIX) in June 2010.
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