AbbVie, in cooperation with Neurocrine Biosciences, Inc., announced that the FDA approved ORIAHNN™ (elagolix, estradiol, and norethindrone acetate capsules; elagolix capsules), with a treatment duration of up to 24 months. ORIAHNN is the first FDA-approved non-surgical, oral medication option for the management of heavy menstrual bleeding associated with uterine fibroids in pre-menopausal women. ORIAHNN is expected to be available in the U.S. by the end of June 2020.
Ayman Al-Hendy, M.D., Ph.D., investigator for the ELARIS UF-2 clinical trials, and professor of gynecology and director of translational research at the University of Illinois at Chicago
“Women who experience heavy menstrual bleeding as a symptom not only deal with the physical toll of uterine fibroids, but also the burdens surrounding its management while trying to get through with their day-to-day routines. This approval provides women with a non-surgical option to help address unresolved heavy menstrual bleeding in an impactful way.”
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.
Michael Severino, M.D., vice chairman and president, AbbVie
“It is always deeply rewarding when the years of development our researchers and scientists dedicate to creating a new way to treat patients is successful. ORIAHNN signifies an important advance in how we can care for women with uterine fibroids.”
In the two, randomized Phase 3 uterine fibroid clinical trials, ELARIS UF-I and ELARIS UF-II, ORIAHNN achieved the primary endpoint of clinically meaningful reduction in bleeding (defined as the proportion of women who achieved both at least a 50 percent reduction in menstrual blood loss at final month of treatment and a total menstrual blood loss amount of less than 80 ml)...
Full text at GMPnews.Net