FDA approves oral therapy for heavy menstrual bleeding associated with uterine fibroids
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The FDA recently approved an oral estrogen and progestin combination capsule for the management of heavy menstrual bleeding associated with uterine fibroids in premenopausal women, according to an agency press release.
The approval of the oral capsule (Oriahnn, AbbVie), a combination of elagolix (Orilissa, AbbVie), estradiol and norethindrone acetate, marks the first FDA-approved medical treatment option specifically for uterine fibroids, according to the agency.
“Uterine fibroids are the most common benign tumors affecting premenopausal women, and one of the most common symptoms from fibroids is heavy menstrual bleeding,” Christine P. Nguyen, MD, acting director of the division of urology, obstetrics and gynecology in FDA’s Center for Drug Evaluation and Research, said in the release. “Although surgical treatments, such as hysterectomy, are available, patients may not qualify for surgery or want the procedure. Various non-surgical therapies are used to treat fibroid-related heavy menstrual bleeding, but none have been FDA-approved specifically for this use.”
Fibroids can occur at any age but are most common in women aged 35 to 49 years, according to the FDA. They typically resolve after menopause but are a leading reason for hysterectomy in the United States when they cause severe symptoms.
As Healio previously reported, women with uterine fibroids assigned a combination of elagolix 300 mg taken twice per day with “add-back” therapy — estradiol 1mg and norethindrone acetate 0.5 mg — were more likely to experience menstrual blood loss at 6 months that was 50% lower vs. baseline and experience less than 80 mL of menstrual blood in month 6 compared with similar women assigned placebo (68.5% vs. 8.7%; P < .001). In findings reported in The New England Journal of Medicine, researchers wrote that menstrual blood loss at 6 months decreased by 194.7 mL from baseline for those assigned elagolix and add-back therapy, by 236.2 mL for those assigned elagolix alone and by 2.3 mL for those assigned placebo (P < .001). Additionally, the researchers noted that 62% of women achieved at least a 2-g/dL rise in hemoglobin after having a baseline measure of 10.5 g/dL or lower when treated with elagolix and add-back therapy.
In a second study, women with uterine fibroids treated with elagolix and add-back therapy were similarly more likely to reach the primary endpoint compared with women assigned placebo (77% vs. 10%; P < .001).
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. Health care professionals may recommend a bone mineral density assessment when starting treatment with Oriahnn and periodically while on treatment.
The most common adverse effects were vasomotor symptoms, headache, fatigue and irregular vaginal bleeding.
Oriahnn includes a boxed warning about risk for stroke and thrombotic or thromboembolic disorders, especially in women at increased risk for these events. The treatment is also contraindicated in women with a history of or current blood clots and in women at increased risk for blood clots, including women aged 35 years and older who smoke or women with uncontrolled hypertension. Other contraindications include known osteoporosis, history of or current breast cancer or other hormonally-sensitive cancer, liver disease or undiagnosed abnormal uterine bleeding.
Oriahnn does not prevent pregnancy and the FDA advises women to use non-hormonal contraception during treatment and for 1 week after discontinuing medication. The treatment may delay the detection of a pregnancy because it changes menstrual bleeding patterns. Oriahnn may also increase blood pressure, which should be monitored in women with controlled hypertension during treatment. Health care providers should advise women on signs and symptoms of liver injury, and women should seek medical attention if they experience suicidal ideation or behavior, new-onset or worsening depression, anxiety or other mood changes. Women taking Oriahnn may experience alopecia. There is a risk of allergic reaction with Oriahnn because its inactive ingredient, FD&C Yellow No. 5 (tartrazine) may cause allergic-type reactions, including bronchial asthma, in some women.
Oriahnn must be dispensed with a patient medication guide that describes important information about the drug’s uses and risks, according to the FDA. – by Regina Schaffer
Disclosures: Nguyen is acting director of the division of urology, obstetrics and gynecology in FDA’s Center for Drug Evaluation and Research.
Perspective
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Nanette Santoro, MD
This treatment is long overdue. We have waited a long time for an orally active — not injection — GnRH antagonist for years to help women with problems that are related to their menstrual cycles, including fibroids, premenstrual dysphoric disorder and migraines in some cases. This compound can abolish menstrual cyclicity and make lots of these symptoms go away. Bleeding in women with fibroids is a tremendously disruptive problem and can cause women to have sudden, shockingly heavy bleeding that can occur without warning. This will certainly help. However, the devil is always in the details.
There are some potentially problematic considerations for Oriahn:
First, Elagolix itself for use in women with endometriosis, without any “add-back” hormones, is very expensive. I do not know the price point for Oriahnn, but if it is anywhere close to elagolix alone, it is going to be out of reach for many women.
Second, the “add-back” hormones provided in Oriahnn are a bit disappointing. As an endocrinologist, I would rather give a more individualized regimen of hormones back to my patients than a one-size-fits-all dose. This is especially true for women who experience bone loss on medications like elagolix, because they may need a higher dose, and Oriahnn restricts options.
Finally, fibroids that are big enough to cause bleeding and severe symptoms are not likely to be amenable to long-term control with medication and will wind up being treated surgically anyway. My preferred use for medical management for fibroids is for women who are close to menopause to “tide them over” and try to get them to menopause without the need for surgery. Oriahnn will be most helpful for these women. However, there are some contraindications that may make it harder to use in this age group. Women who are aged 35 years and older who smoke or women with uncontrolled hypertension won’t be able to use Oriahnn.
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