Allergan: FDA Accepts NDA For Ulipristal Acetate For Uterine Fibroids

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

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

Ulipristal acetate is a selective progesterone receptor modulator or SPRM, which acts directly on the progesterone receptors in three target tissues: the endometrium, uterine fibroids, and the pituitary gland.

David Nicholson, Chief Research and Development Officer of Allergan said, "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."

According to an analysis published by the Agency for Healthcare Research and Quality or AHRQ, an agency within the United States Department of Health and Human Services, in the U.S. an estimated 26 million women between the ages of 15 and 50 years old have uterine fibroids, and at least half of these women have symptoms that may impact the routine activities of their daily lives.

Currently, surgery is a common treatment option for symptomatic uterine fibroids. In fact, uterine fibroids are responsible for over 350,000 hospitalizations and are the leading cause of hysterectomies, accounting for more than one-third of all hysterectomies annually in the U.S.

The economic burden of uterine fibroids is also large, costing the economy up to $34 billion each year.