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Allergan Receives Complete Response Letter from the U.S. Food and Drug Administration for Ulipristal Acetate New Drug Application

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Allergan Receives Complete Response Letter from the U.S. Food and Drug Administration for Ulipristal Acetate New Drug Application

PR Newswire

DUBLIN, Aug. 21, 2018 /PRNewswire/ -- Allergan plc (NYSE:AGN) today 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.

Allergan plc logo (PRNewsFoto/Allergan plc) (PRNewsfoto/Allergan plc)

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.

About Ulipristal Acetate
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.

About Allergan plc
Allergan plc (NYSE:AGN), headquartered in Dublin, Ireland, is a bold, global pharmaceutical leader. Allergan is focused on developing, manufacturing and commercializing branded pharmaceutical, device, biologic, surgical and regenerative medicine products for patients around the world.

Allergan markets a portfolio of leading brands and best-in-class products for the central nervous system, eye care, medical aesthetics and dermatology, gastroenterology, women's health, urology and anti-infective therapeutic categories.

Allergan is an industry leader in Open Science, a model of research and development, which defines our approach to identifying and developing game-changing ideas and innovation for better patient care. With this approach, Allergan has built one of the broadest development pipelines in the pharmaceutical industry.

Allergan's success is powered by our global colleagues' commitment to being Bold for Life. Together, we build bridges, power ideas, act fast and drive results for our customers and patients around the world by always doing what is right.

With commercial operations in approximately 100 countries, Allergan is committed to working with physicians, healthcare providers and patients to deliver innovative and meaningful treatments that help people around the world live longer, healthier lives every day.

For more information, visit Allergan's website at www.Allergan.com.

Forward-Looking Statement
Statements contained in this press release that refer to future events or other non-historical facts are forward-looking statements that reflect Allergan's current perspective on existing trends and information as of the date of this release. Actual results may differ materially from Allergan's current expectations depending upon a number of factors affecting Allergan's business. These factors include, among others, the difficulty of predicting the timing or outcome of FDA approvals or actions, if any; the impact of competitive products and pricing; market acceptance of and continued demand for Allergan's products; the impact of uncertainty around timing of generic entry related to key products, including RESTASIS®, on our financial results; risks associated with divestitures, acquisitions, mergers and joint ventures; uncertainty associated with financial projections, debt reduction, projected cost reductions, projected synergies, restructurings, increased costs, and adverse tax consequences; difficulties or delays in manufacturing; and other risks and uncertainties detailed in Allergan's periodic public filings with the Securities and Exchange Commission, including but not limited to Allergan's Annual Report on Form 10-K for the year ended December 31, 2017 and Allergan's Quarterly Report on Form 10-Q for the period ended June 30, 2018. Except as expressly required by law, Allergan disclaims any intent or obligation to update these forward-looking statements.

CONTACTS:      

Allergan:
Investors:
Daphne Karydas
(862) 261-8006

Karina Calzadilla
(862) 261-7328

Media Relations:
Amy Rose
(862) 289-3072

Fran DeSena
(862) 261-8820

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SOURCE Allergan plc

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