- Allergan's treatment for bleeding caused by uterine fibroids, already approved in Canada and Europe, could add the U.S. to that list in the not-too-distant future, with new top-line data cementing safety and effectiveness.
- Uterine fibroids are benign tumors that develop in the womb and affect as many as 80% of women in the U.S. by age 50. While women with the condition often show no symptoms, some demonstrate abnormal bleeding and pregnancy complications.
- Allergan's drug, ulipristal acetate, targets a steroid called progesterone. In the second of two Phase 3 trials testing the drug in patients with uterine fibroids who showed abnormal bleeding, over half of those receiving the treatment in 10 mg doses had no bleeding after 12 weeks compared to zero in the placebo group.
Allergan said in statement Tuesday it plans to submit ulipristal acetate for approval with the Food and Drug Administration in the second half of the year, likely meaning the agency will decide on approval sometime in early 2018.
Should the drug pass muster with the FDA, it would find itself in a fairly empty market. Most treatments simply work to decrease menstrual bleeding. A notable exception is AbbVie's Lupron Depot (leuprolide acetate for depot suspension), which gained FDA approval in 1999 and works to shrink uterine fibroids.
The drug would also add revenue to Allergan's women's health portfolio. Such products brought in $305.3 million during the third quarter, up 14% from the same period in 2015. The Irish biopharma attributed that growth to price and volume increases for its drugs Lo Loestrin, Estrace Cream and Minastrin.
Ulipristal acetate is available in Canada as Fibristal and Europe as Esmya. The most recent clinical results for the drug come from a Phase 3 randomized, double-blind, placebo-controlled trial that enrolled 432 women, two-thirds of whom were African-American or black. Uterine fibroids are four times more common among African Americans than Caucasians.
The drug met all co-primary and secondary endpoints, which centered on absence of bleeding. Its most common side effects included fatigue, headache and nausea, though Allergan did not disclose whether there were any severe adverse events in its Jan. 17 statement.