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FDA Approves Botox Cosmetic (OnabotulinumtoxinA) for the Temporary Improvement in the Appearance of Moderate to Severe Forehead Lines

DUBLIN, Oct. 3, 2017 /PRNewswire/ -- Today Allergan plc (NYSE: AGN) announced the FDA approval of Botox Cosmetic for its third indication, the temporary improvement in the appearance of moderate to severe forehead lines associated with frontalis muscle activity in adults. This approval makes the brand the first and only neurotoxin indicated for three facial treatment areas - forehead lines, crow's feet lines and glabellar lines.1 As the category leader, Botox Cosmetic is also the only neurotoxin brand to receive approval of aesthetic indications beyond glabellar lines in the U.S.

"Allergan recognizes that forehead lines are a top area of concern for patients,2" says David Nicholson, Chief Research and Development Officer at Allergan. "Our goal in pursuing a third indication for Botox Cosmetic for the temporary improvement in the appearance of moderate to severe forehead lines was based on our desire to study the patient selection, dosing and injection pattern to help provide optimal treatment outcomes."

The Botox Cosmetic story began in 2002 when the brand helped establish the aesthetic market with its first FDA approval to temporarily improve the appearance of moderate to severe frown lines between the eyebrows (glabellar lines). The momentum continued in 2013 when Botox Cosmetic was approved for the temporary improvement in the appearance of moderate to severe crow's feet lines.3,4 The addition of this third indication furthers Allergan's mission to continue providing patients and physicians with products designed to address specific patient needs.

"As a physician, I've been using Botox Cosmetic since it was FDA approved in 2002,3 but for years my patients have also inquired about how to treat forehead lines. With this latest indication for Botox Cosmetic, I have an FDA-approved product I already know and trust, that can improve the appearance of the forehead,1" says Dr. Steven Fagien, an Oculoplastic Surgeon in Boca Raton, Florida and lead clinical trial investigator. "I am proud to have worked closely with Allergan to establish criteria for proper patient selection, dosing and injection pattern for forehead line treatment and am pleased to see that the company is providing extensive injector training to help ensure optimal results."

"Few products have the level of impact that Botox Cosmetic has had on the medical facial aesthetics industry," said David Moatazedi, Senior Vice President U.S. Medical Aesthetics at Allergan. "Botox Cosmetic is the brand that created a new category in facial aesthetics with its first FDA approval 15 years ago.3 Since then it has continued to be the leading neurotoxin treatment and the world's number one selling product of its kind."5

In clinical trials, Botox Cosmetic demonstrated efficacy compared with placebo in the reduction of the severity of forehead lines, as assessed by both the investigator and the subject at Day 30 (primary endpoint): 61% of subjects in study one and 46% of subjects in study two met the primary endpoint compared with placebo (0% in Study one and 1% in Study two). Similar response rates were seen across three treatments cycles with Botox Cosmetic.1

Approved for use in over 75 countries, Botox Cosmetic is the most widely researched and studied treatment of its kind.6,7 The safety and efficacy have been evaluated in Allergan clinical studies and described in nearly 500 peer-reviewed articles in scientific and medical journals.7,8 Botox Cosmetic is manufactured in a state-of-the art facility under strict quality and safety standards.

To learn more about Botox Cosmetic please visit www.botoxcosmetic.com or www.botoxcosmetic.com/men. Consumers can also save money on Botox Cosmetic and other Allergan aesthetic treatments through the Brilliant Distinctions customer loyalty program, which has grown to more than three million members. Visit www.brilliantdistinctions.com to enroll.

Approved Uses

Botox Cosmetic is a prescription medicine that is injected into muscles and used to temporarily improve the look of moderate to severe forehead lines, crow's feet lines, and frown lines between the eyebrows in adults.

References:

1 BOTOX® Cosmetic Prescribing Information 2017.
2 Data On File Allergan, Inc.; Facial Injectables Patient Records Tracking Study Neurotoxins, 2016.
3 Department of Health and Human Services FDA-Approval Letter for BOTOX® Cosmetic for Glabellar Lines, 2002.
4 FDA News Release, BOTOX® Cosmetic FDA-approval letter for Crow's Feet (http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm367662.htm), 2013.
5 Data On File Allergan, Inc.; 2016 A&U Neurotoxins Data on File, BOTOX® Cosmetic 2015 WW Leader in Cosmetic NM Market, 2015.
6 BOTOX® Cosmetic Website, (https://www.botoxcosmetic.com/?cid=sem_goo_43700008344046928)
7 Data On File Allergan, Inc.; Peer-Reviewed Articles, 2015.
8 Data On File Allergan, Inc.; Patient Clinicals, 2015.

About Allergan plc

Allergan plc (NYSE: AGN), headquartered in Dublin, Ireland, is a bold, global pharmaceutical company and a leader in a new industry model – Growth Pharma. 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 with 65+ mid-to-late stage pipeline programs currently in development.

Allergan's success is powered by our more than 18,000 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; 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, 2016 and Allergan's Quarterly Report on Form 10-Q for the period ended June 30, 2017. Except as expressly required by law, Allergan disclaims any intent or obligation to update these forward-looking statements.

SOURCE Allergan plc

Posted: October 2017

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