FDA accepts Allergan’s new drug application for Ulipristal Acetate for Uterine Fibroids

Allergan announced that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for ulipristal acetate, an investigational drug for the treatment of abnormal uterine bleeding in women with uterine fibroids.

“Women with symptomatic uterine fibroids may suffer from physical and emotional distress2,3 without realizing their symptoms are caused by a treatable medical condition,” said David Nicholson, Ph.D., Chief Research and Development Officer, Allergan. “Even when diagnosed, women in the U.S. are faced with limited treatment options. We are eager to continue working with the FDA on the potential approval of the first, once-daily oral treatment for abnormal uterine bleeding in women with uterine fibroids.”

“Uterine fibroids have a serious impact on public health, and I am hopeful ulipristal acetate will offer millions of women a new, non-surgical treatment option that will help them manage their uterine fibroids,” said Millie A. Behera M. D., FACOG, Reproductive Endocrinology and Fertility Medical Director, Bloom Reproductive Institute. “It is welcome news for physicians to learn about the possibility of an oral treatment option, and that’s exactly what U.S. physicians can look forward to if the investigational drug ulipristal acetate is approved for abnormal uterine bleeding in women with uterine fibroids.”

Allergan expects the ulipristal acetate Prescription Drug User Fee Act (PDUFA) action date to occur in the first half of 2018.