Health Canada approves Actavis drug for uterine fibroids

PARSIPPANY, N.J. — Canadian regulators have approved a drug for treating a condition that affects up to three-quarters of women and causes excessive bleeding from the uterus.

Actavis announced Tuesday that Health Canada had approved Fibristal (ulipristal acetate) for treating moderate to severe signs and symptoms of uterine fibroids in women of reproductive age who are eligible for surgery. Up to 75% of women will experience uterine fibroids in their lifetime, according to the Mayo Clinic, with painful menstruation, pelvic pain and frequent urination as common symptoms; the condition can also lead to infertility.

"The approval of Fibristal marks our entry into this important therapeutic area and provides an innovative new treatment option for women whose fibroid symptom severity often leads to excessive bleeding and related pain," Actavis specialty brands president Fred Wilkinson said. "As a global leader in women's health, Actavis is committed to developing innovative medications to fill unmet medical needs of women in Canada and around the world."

Actavis markets a higher-dose formulation of ulipristal acetate in the United States as a contraceptive under the brand name Ella.

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