The FDA Approves the First Oral Treatment for Fibroids Symptoms, Offering a New Non-Surgical Option
“There’s the documented potential for psychological burden among women suffering from symptomatic uterine fibroids. Studies show that uterine fibroid-associated symptoms can affect women’s work, family and social activities,” Charlotte Owens, MD, medical director at AbbVie, the company who created Oriahnn, tells Forbes. “With the FDA’s approval, this therapy provides an important new option for the millions of people living with uterine fibroids who, for the first time, have a non-surgical, oral treatment option that is specifically approved to treat their heavy menstrual bleeding.”
Expected to be available by the end of June, Oriahnn combines estrogen, progestin, and elagolix (a gonadotropin-releasing hormone) to decrease heavy fibroid-related bleeding. It is a hormonal pill, but it does not prevent pregnancy. Those who take it and wish to prevent pregnancy must also use non-hormonal forms of birth control. A major side effect of long-term use is bone density loss, so it's recommended that Oriahnn is only used for a maximum of two years.
Two clinical trials were conducted to test Oriahnn. A total of 591 premenopausal women with heavy menstrual bleeding (defined as having at least two menstrual cycles with greater than about a third of a cup of menstrual blood loss) received the drug or a placebo for six months. The goal was for the women to lose less blood by the final month and to have a 50 percent or greater reduction in menstrual blood loss. In the first study, 68.5 percent of those who received the drug hit these benchmarks (compared to 8.7 percent of patients who received a placebo). In the second study, 76.5 percent of those who received Oriahnn achieved this endpoint (compared to 10.5 percent of patients who received a placebo).
When it comes to treating fibroids, Erica March, MD, a reproductive endocrinologist and infertility specialist, says that many of the medical treatments target the symptoms instead of the actual tumors. She explains that there are two other non-surgical options for managing heavy fibroid-related bleeding including hormonal contraceptives and leuprolide acetate, a synthetic gonadotropin-releasing hormone that puts women into a temporary menopausal state. "Women can get those injections once a month or once every three months depending on the dosage, and that is effective in both shrinking the fibroids and also stopping the bleeding and helping them improve their, their blood counts and recover from anemia," she says. Leuprolide acetate is also used to treat endometriosis symptoms and prostate cancer.
While these treatments are commonly used, they aren't FDA-approved to specifically decrease heavy fibroid-related bleeding. "Various non-surgical therapies are used to treat fibroid-related heavy menstrual bleeding, but none have been FDA-approved specifically for this use," says Christine P. Nguyen, MD, acting director of the Division of Urology, Obstetrics and Gynecology in FDA’s Center for Drug Evaluation and Research in a statement. "[The Oriahnn] approval provides an FDA-approved medical treatment option for these patients.”
Many who have fibroids don't get any symptoms, but if you are experiencing symptoms and would like to get screened for fibroids, Dr. Marsh says to speak to a trusted health care provider. "Any reproductive age woman who is noticing bloating and heavy menstrual bleeding and fatigue should inquire with their provider," she says. "The screening for fibroids is very simple, an ultrasound can be sufficient in making the diagnosis."
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