17/08/2020
Treatment approved for heavy menstrual bleeding associated with fibroids
Maria G. Tanzi
Oriahnn (AbbVie) is the first and only FDA-approved oral treatment for the management of heavy menstrual bleeding associated with uterine leiomyomas (fibroids) in premenopausal women. The treatment is a combination capsule containing elagolix 300 mg, estradiol 1 mg, and norethindrone 0.5 mg for the morning dose copackaged with a capsule of elagolix 300 mg for the evening dose.
Uterine fibroids, common benign tumors in premenopausal women, can have a significant impact on quality of life, with symptoms such as heavy menstrual bleeding, pain, and bowel and bladder issues. Treatment options have included various surgical procedures such as hysterectomy and myomectomy, and medical therapies to reduce heavy menstrual bleeding (e.g., hormonal contraceptives, tranexamic acid, and NSAIDs).
“Although surgical treatments, such as hysterectomy, are available, patients may not qualify for surgery or want the procedure,” said Christine P. Nguyen, MD, acting director, division of Urology, Obstetrics and Gynecology in FDA’s Center for Drug Evaluation and Research in an FDA news release.
She noted that “various non-surgical therapies are used to treat fibroid-related heavy menstrual bleeding, but none have been FDA-approved specifically for this use.” The approval of Oriahnn now offers patients a nonsurgical option to help manage their condition.