Estradiol/Norethindrone Acetate

Oriahnn is the new non-surgical treatment for heav AbbVie won first-of-its-kind approval for a non-surgical treatment, Oriahnn, aimed at treating heavy menstrual bleeding due to uterine fibroids, a common non-cancerous tumor, in pre-menopausal women. Oriahnn is the new non-surgical treatment for heavy menstrual bleeding. AbbVie won a first-of-its-kind approval for a non-surgical treatment aimed at treating heavy menstrual bleeding due to uterine fibroids, a common non-cancerous tumor, in pre-menopausal women. On Friday, the U.S. Food and Drug Administration approved an oral drug, Oriahnn (elagolix, estradiol, and norethindrone acetate capsules; elagolix capsules), which was co-developed by AbbVie and Neurocrine Biosciences, for the management of heavy menstrual bleeding due to uterine fibroids in pre-menopausal women. Oriahnn is an oral combination of elagolix and E2/NETA (estradiol/norethindrone acetate). The two companies previously won approval for elagolix as a treatment for endometriosis-associated pain. ad (adsbygoogle = window.adsbygoogle || []).push({}); Uterine fibroids, also called leiomyomas, are noncancerous tumors but they can cause debilitating symptoms, including abnormal uterine bleeding, heavy or painful periods, anemia, abdominal pain, backache, increased abdominal girth and bloating. Uterine fibroids affect up to 70% of Caucasian women and up to 80% of African American women by age 50. Uterine fibroids are traditionally managed by surgery and are the leading cause of hysterectomies. Studies show that uterine fibroids-associated symptoms can affect women’s work, family, and social activities. The companies anticipate Oriahnn to be available in the United States by the end of July. Ayman Al-Hendy, a professor of gynecology from the University of Chicago and the lead investigator of the Phase III studies of Oriahnn, said heavy menstrual bleeding associated with uterine fibroids creates an undue burden as they try to go through their day-to-day routines. The FDA approval of Oriahnn provides these women with a non-surgical option to address these challenges. Oriahnn was approved based on two, randomized Phase III studies , ELARIS UF-I and ELARIS UF-II. In those trials, Oriahnn demonstrated a 50% reduction in menstrual blood loss at the final month of treatment and a total menstrual blood loss amount of less than 80 ml, compared with placebo. At the end of the study, 70% of women no longer experienced heavy menstrual bleeding compared to 10% of women on placebo. Additionally, trial results, which were published in The New England Journal of Medicine, showed the medication reduced heavy menstrual bleeding due to uterine fibroids by 50% within the first month of use. “It is always deeply rewarding when the years of development our researchers and scientists dedicated 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,” AbbVie President Michael Severino said in a statement. While Oriahnn is generally safe, there are some safety risks, including bone density issues if a patient takes the drug longer than two years, as well as an increased risk of cardiovascular issues, including heart attack and stroke, particularly for patients who smoke. Earlier this year, Myovant announced plans to seek regulatory approval for its uterine fibroid treatment following an 88% one-year response rate from an extension study of an oral relugolix combination therapy in women with heavy menstrual bleeding associated with uterine fibroids. hbspt.forms.create({ portalId: "4413123", formId: "c4dda430-e2b0-4083-86f3-ccce0c1d4479" });