FDA Approves New Treatment for Menstrual Bleeding Associated With Fibroids

Officials with the FDA have approved the oral combination of elagolix, estradiol, and norethindrone acetate capsules; elagolix capsules (Oriahnn, AbbVie and Neurocrine Biosciences) with a treatment duration of up to 24 months.^1,2

This therapy is the first FDA-approved nonsurgical, oral medication option for the management of heavy menstrual bleeding associated with uterine fibroids in premenopausal women, according to AbbVie.¹

The combination of elagolix and E2/NETA (estradiol/norethindrone acetate) are expected to be available in the United States by the end of June 2020.¹

"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," said Ayman Al-Hendy, MD, PhD, investigator for the ELARIS UF-2 clinical trials, and professor of gynecology and director of translational research at the University of Illinois at Chicago, in a prepared statement.¹

Uterine fibroids, also called leiomyomas, are estrogen- and progesterone-dependent noncancerous tumors of the uterus and are the most common type of benign tumor in women of reproductive age, affecting up to 70% of Caucasian women and up to 80% of African American women by age 50 years. Uterine fibroids have been traditionally managed by surgery in the United States, primarily, and are the leading reason for hysterectomies.^1,2

The efficacy of elagolix and E2/NETA was established in 2 clinical trials in which 591 premenopausal women with heavy menstrual bleeding received the drug or placebo for 6 months.²

In the randomized phase 3 uterine fibroid clinical trials, ELARIS UF-I and ELARIS UF-II,¹ elagolix and E2/NETA achieved the primary endpoint of clinically meaningful reduction in bleeding (defined as the proportion of women who achieved both at least a 50% reduction in menstrual blood loss at final month of treatment and a total menstrual blood loss amount of less than 80 ml), compared with placebo in final month of study for patients.

Seven of 10 women no longer experienced heavy menstrual bleeding versus 1 of 10 women on placebo (P<0.001 for both trials), according to the study. The therapy also reduced heavy menstrual bleeding due to uterine fibroids by 50% within the first month of use.^1,2

This therapy may cause bone loss over time, and the loss in some women may not be completely recovered after stopping treatment. Use of elagolix and E2/NETA should be limited to 24 months due to the risk of continued bone loss, which may not be reversible.^1,2

The most common adverse effects of the combination drug were hot flushes, headache, fatigue and irregular vaginal bleeding. AbbVie’s drug label for elagolix and E2/NETA includes a Boxed Warning about the risk of vascular events (strokes) and thrombotic or thromboembolic disorders (blood clots).²

Women at increased risk for these events include patients who smoke and are over the age of 35 years with high blood pressure.^1,2 Other contraindications include known osteoporosis, a history of or current breast cancer or other hormonally-sensitive cancer, liver disease, or undiagnosed abnormal uterine bleeding.²

The therapy is taken twice daily (morning and evening) at approximately the same time each day, with or without food.¹

REFERENCES

• FDA Approves the First Oral Medication for the Management of Heavy Menstrual Bleeding Due to Uterine Fibroids in Pre-menopausal Women [news release]. North Chicago, IL; May 29, 2020: AbbVie. https://www.prnewswire.com/news-releases/fda-approves-the-first-oral-medication-for-the-management-of-heavy-menstrual-bleeding-due-to-uterine-fibroids-in-pre-menopausal-women-301067963.html Accessed May 2020.
• FDA Approves New Option to Treat Heavy Menstrual Bleeding Associated with Fibroids in Women [news release]. Silver Spring, MD; May 29, 2020: FDA website. https://www.fda.gov/news-events/press-announcements/fda-approves-new-option-treat-heavy-menstrual-bleeding-associated-fibroids-women Accessed May 2020.