FDA approves drug for heavy menstrual bleeding due to fibroids
The U.S. Food and Drug Administration has approved Oriahnn capsules for the management of heavy menstrual bleeding associated with uterine leiomyomas or fibroids in premenopausal women.Oriahnn is an estrogen and progestin combination product consisting of elagolix, estradiol and norethindrone acetate packaged together for oral use.
The approval of Oriahnn was granted to AbbVie Inc by Food and Drug Administration.
Fibroids are benign muscle tumors of the uterus that can cause heavy menstrual bleeding, pain, bowel or bladder problems and infertility.They occur most commonly in women aged 35-49 years, typically resolve after menopause but are a leading reason for hysterectomy in the United States, according to the release.
The efficacy of Oriahnn was established in two clinical trials in which a total of 591 premenopausal women with heavy menstrual bleeding received the drug or placebo for six months
The participants received the drug or placebo for 6 months. The investigators defined heavy menstrual bleeding as at least two menstrual cycles with greater than 80 mL of menstrual blood loss. The primary endpoint was the proportion of women who achieved menstrual blood loss less than 80 mL at the final month and 50% or greater reduction in menstrual blood loss volume from baseline to the final month. In one trial, 69% of patients who received Oriahnn met this endpoint, compared with 9% of patients who received placebo. In the second study, 77% of patients who received the drug achieved this endpoint, compared with 11% of patients who received placebo.In the first study, 68.5% of patients who received Oriahnn achieved this endpoint (compared to 8.7% of patients who received placebo). In the second study, 76.5% of patients who received Oriahnn achieved this endpoint (compared to 10.5% of patients who received placebo).
"Uterine fibroids are the most common benign tumors affecting premenopausal women, and one of the most common symptoms from fibroids is heavy menstrual bleeding," said Christine P. Nguyen, MD, Acting Director, Division of Urology, Obstetrics and Gynecology in FDA's Center for Drug Evaluation and Research. "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 Food and Drug Administration-approved specifically for this use. Today's approval provides an food and drug administration approved medical treatment option for these patients."
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 density scan (called DXA scan) when starting women on Oriahnn and periodically while on treatment.
The most common side effects of Oriahnn were hot flushes, headache, fatigue and irregular vaginal bleeding. The drug label for Oriahnn includes a Boxed Warning about the risk of strokes and thrombotic or thromboembolic disorders , especially in women at increased risk for these events. Patients should stop Oriahnn if a blood clot, heart attack or stroke occurs. Oriahnn is contraindicated in women with a history of or current blood clots and in women at increased risk for blood clots, including women over 35 years of age who smoke or women with uncontrolled hypertension (high blood pressure). Other contraindications include known osteoporosis, a history of or current breast cancer or other hormonally-sensitive cancer, liver disease or undiagnosed abnormal uterine bleeding.
Oriahnn does not prevent pregnancy. Women should use non-hormonal contraception during treatment and for one week after discontinuing the medication. Oriahnn may delay the detection of a pregnancy because it changes menstrual bleeding patterns. Oriahnn may increase blood pressure, which should be monitored in women with controlled hypertension during treatment with Oriahnn. Patients should be advised on signs and symptoms of liver injury. Patients are advised to seek medical attention if they experience suicidal ideation or behavior, new onset or worsening depression, anxiety or other mood changes. Patients taking Oriahnn may experience hair loss (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.
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