Allergan Gets CRL From FDA For Ulipristal Acetate NDA

(RTTNews) - Allergan plc (AGN) said it received a Complete Response Letter or CRL from the U.S. Food and Drug Administration in response to the New Drug Application or NDA for ulipristal acetate or UPA for the treatment of abnormal uterine bleeding in women with uterine fibroids.

The letter from the FDA indicates it is not able to approve the ulipristal acetate NDA in its current form and is requesting additional information. The agency cited safety concerns regarding ESMYA post-marketing reports outside the United States. Allergan plans to meet with the FDA to discuss their comments and next steps.

The New Drug Application for ulipristal acetate included the results of a robust clinical trial program which included two U.S. Phase 3 clinical trials and all Phase 3 EU registration studies as well as real-world data in more than 700,000 women with uterine fibroids across 80 countries worldwide.

Ulipristal acetate, an investigational drug in the U.S. 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 U.S, 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.