Allergan plc, a leading global pharmaceutical company, announced that it was notified by the US Food and Drug Administration (FDA) that the review of the New Drug Application (NDA) for ulipristal acetate will be extended. The PDUFA target action date has been extended to August 2018 to provide time for a full review of the file.
Ulipristal acetate, an investigational drug in the US for the medical treatment of abnormal uterine bleeding in women with uterine fibroids, is a selective progesterone receptor modulator (SPRM), which acts directly on the progesterone receptors in three target tissues: the endometrium (uterine lining), uterine fibroids, and the pituitary gland. In the US, the safety and efficacy of ulipristal acetate has been evaluated in two North American phase 3 studies (Venus I and VENUS II) of more than 500 adult women of reproductive age. Ulipristal acetate is protected by a patent that expires in 2029.
In addition to the Venus I and II trials, the efficacy of ulipristal acetate has been demonstrated in a series of four, multi-center, Phase 3, European trials involving more than 1,000 women with uterine fibroids. In Europe, ulipristal acetate is marketed under the trade name Esmya by Gedeon Richter. In Canada, ulipristal acetate is available under the trade name Fibristal and marketed by Allergan. Esmya and Fibristal are currently approved for the pre-operative and intermittent treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age.
To date, approximately 700,000 women have been treated with ulipristal acetate for fibroids in over 80 countries worldwide.