In a new development today the US Food and Drug Administration granted approval to the drug Oriahnn for the treatment and management of heavy menstrual bleeding associated with fibroids in premenopausal women. This was announced in an official press release on the agency’s website.
This drug Oriahnn is an estrogen and progestin combination product consisting of elagolix, estradiol and norethindrone acetate, which is available in the form of capsules that can be used orally.
The approval for the drug was only granted to one pharmaceutical compnay called AbbVie Inc.
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Fibroids are basically non-cancerous tumors present on the surface of a woman’s uterus and can cause serious complications like heavy bleeding during periods, bowel issues, pain, bladder problems and even infertility.
These are the most common type of uterine tumors that there are. Though benign and formed due to unknown causes, these fibroids can leave women with lasting damage in many cases. These fibroids are also known as leiomyomas, myomas, uterine myomas, and fibromas.
Nearly 20 to 80 presents of the women of reproductive age develop fibroids till the age of 50, according to the National Institutes of Health. They can occur at any age but are most common in women between 35 to 49 years old.
These fibroids often resolve themselves when women reach menopause but, in many cases, when the symptoms are too severe women have to undergo hysterectomy (surgical removal of the uterus). In US, this is the most common cause of hysterectomies.
Many of the women who do have sever symptoms sometimes do not qualify for the treatment and do not want to undergo such a radical procedure. Till date, no no-surgical therapies have been approved by the FDA to treat heavy bleeding in such cases.
Women that are pregnant, has a family history of fibroids, are more than 30 years old, are African American, and have high body weight are more likely to need this treatment as they are more likely to develop fibroids.This is the first time that FDA has given approval for any kind of drug therapy to treat heavy bleeding in premenopausal women suffering from fibroids.
The approval given to Oriahnn was based on two clinical trials that were conducted to measure the efficacy of the drug. A total of 591 women participated in the said trials and received either the drug or a placebo for 6 months, to treat heavy menstrual bleeding.
Heavy bleeding was defined as two consecutive periods with greater than 80 mL (about a third of a cup) of menstrual blood loss. Women who then had a menstrual blood loss less than 80 mL at the final month and 50 percent reduction in this blood loss, were defined as successful result subjects.
In the first study, 68.5 percent of the women who received Oriahnn were successfully treated, compared to 8.7% of patients who received placebo.
And in the second study, 76.5 percent of the women who received Oriahnn were successfully treated, compared to 10.5% of patients who received placebo.
The important thing to note here is that there are a lot of side effects associated with this drug like hot flushes or sudden feelings of warmth, fatigue, headache, hair loss, depression, anxiety, allergic reaction and irregular vaginal bleeding.
The drug also comes with an increased risk of vascular events or strokes and thrombotic or thromboembolic disorders, commonly known as blood clots. The risk is especially high in women who have the history of blood clots. Patients suffering from such a condition should not take this drug according to the FDA.
Women above the age of 35 who smoke, have hypertension, have history of breast cancer, any other hormonally sensitive cancer, liver disease, or undiagnosed abnormal bleeding cannot use this drug. Oriahnn can also cause bone loss over time, which is often irreversible.
Oriahnn does not prevent pregnancy, can delay detection of a pregnancy, and can cause increased blood pressure in women.