AbbVie Submits New Drug Application to US FDA for Investigational Elagolix for Management of Heavy Menstrual Bleeding Associated with Uterine Fibroids in Women
AbbVie Inc. (ABBV)
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Source: PR Newswire
NORTH CHICAGO, Ill., Aug. 5, 2019 /PRNewswire/ -- AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, in cooperation with Neurocrine Biosciences, Inc. (NASDAQ: NBIX), today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for elagolix, an investigational, oral gonadotropin-releasing hormone (GnRH) antagonist, for the management of heavy menstrual bleeding (HMB) associated with uterine fibroids in women. Uterine fibroids are non-cancerous, hormonally-responsive muscle tissue tumors of the uterus.1 They can affect up to 70% of Caucasian women and up to 80% of African American women by age 50.2 Fibroids can be asymptomatic but, in some women, fibroids can cause symptoms, such as heavy menstrual bleeding (HMB), vaginal bleeding at times other than menstruation, and anemia.1,3 "This submission brings us closer to our goal of improving care for women who continue to struggle with the often disruptive effects of uteri
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