AbbVie (ABBV), in cooperation with Neurocrine Biosciences Inc. (NBIX), said that the U.S. Food and Drug Administration approved Oriahnn capsules, co-packaged for oral use, for the management of heavy menstrual bleeding associated with uterine leiomyomas (fibroids) in premenopausal women.
The approval provides women with a non-surgical option to help address unresolved heavy menstrual bleeding in an impactful way.
Oriahnn is expected to be available in the U.S. by the end of June 2020.
The FDA warned that Oriahnn may cause bone loss over time, and the loss in some women may not be completely recovered after stopping treatment. Because bone loss may increase the risk for fractures, women should not take Oriahnn for more than 24 months.
Uterine fibroids, also called leiomyomas, are estrogen and progesterone-dependent non-cancerous tumors of the uterus and are the most common type of benign tumor in women of reproductive age, affecting up to 70 percent of Caucasian women and up to 80 percent of African American women by age 50. Traditionally, uterine fibroids have been primarily managed by surgery and are the leading reason for the hysterectomies performed in the U.S.