10.03.2017 | Investors

FDA Approves BOTOX® Cosmetic (OnabotulinumtoxinA) for the Temporary Improvement in the Appearance of Moderate to Severe Forehead Lines Associated with Frontalis Muscle Activity In Adults


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 plc logo

"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.

BOTOX® Cosmetic may cause serious side effects that can be life threatening. Get medical help right away if you have any of these problems any time (hours to weeks) after injection of BOTOX® Cosmetic:

  • Problems swallowing, speaking, or breathing, due to weakening of associated muscles, can be severe and result in loss of life. You are at the highest risk if these problems are pre-existing before injection. Swallowing problems may last for several months.
  • Spread of toxin effects. The effect of botulinum toxin may affect areas away from the injection site and cause serious symptoms including: loss of strength and all-over muscle weakness, double vision, blurred vision and drooping eyelids, hoarseness or change or loss of voice, trouble saying words clearly, loss of bladder control, trouble breathing, trouble swallowing

BOTOX® Cosmetic dosing units are not the same as, or comparable to, any other botulinum toxin product.

There has not been a confirmed serious case of spread of toxin effect when BOTOX® Cosmetic has been used at the recommended dose to treat frown lines, crow's feet lines, and/or forehead lines.

BOTOX® Cosmetic may cause loss of strength or general muscle weakness, vision problems, or dizziness within hours to weeks of taking BOTOX® Cosmetic. If this happens, do not drive a car, operate machinery, or do other dangerous activities.

Serious and/or immediate allergic reactions have been reported. They include: itching, rash, red itchy welts, wheezing, asthma symptoms, or dizziness or feeling faint. Get medical help right away if you are wheezing or have asthma symptoms, or if you become dizzy or faint.

Do not receive BOTOX® Cosmetic if you: are allergic to any of the ingredients in BOTOX® Cosmetic; had an allergic reaction to any other botulinum toxin product; have a skin infection at the planned injection site.

Tell your doctor about all your muscle or nerve conditions,

Tell your doctor about all your medical conditions, including: if you are or plan to become pregnant or breast feed.

Tell your doctor about all the medicines you take. Using BOTOX® Cosmetic with certain other medicines may cause serious side effects. Do not start any new medicines until you have told your doctor that you have received BOTOX® Cosmetic in the past.

Tell your doctor if you have received any other botulinum toxin product in the last 4 months; have recently received an antibiotic by injection; take muscle relaxants; take an allergy or cold medicine; take a sleep medicine; take aspirin-like products or blood thinners.

The most common side effects of BOTOX® Cosmetic include: discomfort or pain at the injection site; headache; and eye problems: double vision, blurred vision, drooping eyelids and eyebrows, and swelling of your eyelids.

For more information refer to the Medication Guide or talk with your doctor.

To report a side effect, please call Allergan at 1-800-433-8871.

Please see full Prescribing Information, including Boxed Warning, for BOTOX® Cosmetic.

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.

© 2017 Allergan. All rights reserved. All trademarks are the property of their respective owners.




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