The Food and Drug Administration has accepted the New Drug Application (NDA) for Esmya (ulipristal acetate; Allergan) for the treatment of abnormal uterine bleeding in women with uterine fibroids.
Ulipristal acetate is a selective progesterone receptor modulator which acts directly on the progesterone receptors in the endometrium, uterine fibroids, and the pituitary gland. The safety and efficacy of ulipristal acetate has been assessed in two Phase 3 studies (VENUS I and VENUS II) in North America, which included more than 500 women of reproductive age. In addition, four, multi-center, Phase 3 European studies have been conducted which included over 1000 women with uterine fibroids.
“Women with symptomatic uterine fibroids may suffer from physical and emotional distress 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.”
Allergan expects the Prescription Drug User Fee Act (PDUFA) action date for Esmya to occur in the first half of 2018.
For more information visit Allergan.com.