Allergan Receives Response Letter from FDA for Ulipristal Acetate

Allergan announced it received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) in response to the New Drug Application (NDA) for ulipristal acetate (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.

"Allergan continues to believe in the need for novel treatment options for women who are looking for a non-surgical treatment for uterine fibroids," said David Nicholson, Chief Research and Development Officer, Allergan. "We intend to meet with the FDA to discuss the Complete Response Letter and determine the potential next steps for our ulipristal acetate NDA."

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.

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.

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