FDA approves new drug for treating uterine fibroids

Women with uterine fibroids may have a new arsenal fighting against this common condition besides hysterectomy, or removal of the uterus.  A new oral medication by Allergan called ulipristal acetate has been accepted by the U.S. Food and Drug Administration (FDA) for the treatment of abnormal bleeding in women with uterine fibroids for marketing approval and could be available as soon as summer 2018.  It is expected that the FDA will make a decision on this new drug sometime in the first half of 2018, under the Prescription Drug User Fee Act. 

Ulipristal acetate has been available in Europe and Canada for several years.  In Europe, ulipristal acetate is marketed by Gedeon Richter under the trade name of Esmya and in Canada, ulipristal acetate is marketed by Allergan under the trade name Fibristal.  Both of these drugs are approved for the intermittent treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age who are eligible for surgery.

The Agency for Healthcare Research and Quality (AHRQ) estimates that 26 million women of reproductive age have uterine fibroids with African American women having the highest rate of this condition.  Uterine fibroids are muscular tumors that grow in the wall of the uterus and are almost always benign or not cancerous.  It is not known what causes them.  Some women will have no symptoms not knowing they are even there while others with symptomatic fibroids may suffer from pain, iron deficiency, fatigue, and heavy menstrual bleeding.  Other symptoms can include pelvic pain or pressure, a swollen abdomen and frequent urination.  Depending on the size and location of fibroids, they can also cause fertility and pregnancy problems. 

Treatment for fibroids depends on the symptoms.  Research shows that over 90% of women newly diagnosed with fibroids will seek medical or surgical treatment for the condition within a year of diagnosis.  Every year, fibroids lead to more than 200,000 hysterectomies.  Women who still want to bear children can have a myomectomy which removes the fibroids while keeping the uterus intact, even though the fibroids can grow back. 

The growth and development of uterine fibroids are caused by the hormone progesterone.  This new medication of ulipristal acetate blocks the effect of progesterone on the endometrium (lining of the uterus), uterine fibroids, and the pituitary gland, the pea-sized body on the base of the brain that controls the functioning of the endocrine glands.  Eventually, the medication will cause the fibroids to shrink, becoming less painful and also stops heavy menstrual bleeding.

Women who have taken this medication take it once a day for three months and then stop for one menstrual cycle allowing the endometrium to shed. The drug appears to have fewer side effects and can result in significantly reduced heavy menstrual bleeding and reductions in the thickness of the endometrium within six months along with a decrease in the size of fibroids.