Welcome!

News Feed Item

Allergan's BOTOX® (botulinum toxin type A) Receives National Marketing Authorisation for Treatment of Moderate to Severe Crow's Feet Lines in Adult Patients

MARLOW, England, January 9, 2014 /PRNewswire/ --



New aesthetic indication for market-leading neuromodulator which can now help improve appearance of lines around the eyes, as well as treating glabellar frown lines

Today, Allergan, Inc. announced that BOTOX® has received the licence from the Medicines and Healthcare products Regulatory Agency (MHRA) for the temporary improvement in the appearance of moderate to severe lateral canthal lines (crow's feet lines) seen at maximum smile, either alone or when treated at the same time as glabellar (or frown) lines seen at maximum frown, in adult patients where these facial lines have an important psychological impact. This marketing authorisation is specific to Allergan's botulinum toxin type A product and is based on Allergan's successful global Phase III clinical trial programme in Crow's Feet Lines.

"This latest approval for BOTOX® demonstrates Allergan's continued commitment to excellence in neuromodulator innovation and our long-term leadership in medical aesthetics," said Paul Navarre, President of Allergan Europe, Africa & Middle East. "We are proud to deliver this important innovation to medical aesthetics practitioners in the UK, allowing them for the first time to treat the glabellar and crow's feet areas either alone or simultaneously."

The MHRA licence for the use of BOTOX® to treat crow's feet lines is based on the results of two randomised, multi-centre, placebo-controlled clinical studies involving more than 1,350 patients.[1] These studies met their primary endpoint, demonstrating that patients who received treatment with BOTOX® achieved none or mild lines according to investigator assessment at day 30, compared to those patients who did not receive botulinum toxin type A treatment and this significant reduction in the appearance of crow's feet lines lasted an average of four months post-treatment.[1] In general, patients treated with BOTOX® reported that they looked younger and more attractive.[1] In these studies, Allergan's botulinum toxin type A product was generally well tolerated.[1] Like all medicines, Allergan's botulinum toxin type A product may cause side effects, although the incidence rate is variable. In general, adverse reactions occurred within the first few days following injection and were temporary.[1]

"Crow's Feet Lines are amongst the top ageing concerns for people in the UK and Europe. Whilst these lines form a natural part of our eye expressions, over time they can become fixed or elongated even when our faces are relaxed, which can make us look tired or stressed," said David Eccleston, Clinical Director, MediZen Clinic. "Softening the appearance of Crow's Feet Lines as well as the glabellar lines with BOTOX® can deliver a refreshed and natural look, helping patients to look like themselves again and improve their self-confidence."

Notes to Editor

About BOTOX®

BOTOX® (botulinum toxin type A) is a prescription medication that works by relaxing the specific muscles that cause crow's feet lines or frown lines to form. By decreasing muscle activity, it's possible to soften the appearance of these lines and wrinkles without radically changing facial appearance or making a patient look as if they have had "work done". The temporary effect lasts for up to four months.[1] Patient satisfaction data shows that following treatment with BOTOX®, patients reported looking more relaxed and confident, as well as looking as young as they feel.[2] BOTOX® should only be administered in a clinical setting by an appropriately trained physician.

About Allergan's botulinum toxin type A

Worldwide, approximately 35 million vials of Allergan's botulinum toxin type A products have been distributed over the past 21 years (1990-2012). The safety and efficacy of Allergan's botulinum toxin type A product has been well-established with approximately 65 randomised, placebo-controlled clinical trials involving approximately 15,000 patients and, with more than 2,500 articles in scientific and medical journals, Allergan's neurotoxin is one of the most widely researched medicines in the world.[3]

About Allergan

Allergan is a multi‐specialty health care company established more than 60 years ago with a commitment to uncover the best of science and develop and deliver innovative and meaningful treatments to help people reach their life's potential. Today, we have approximately 11,100 highly dedicated and talented employees, global marketing and sales capabilities with a presence in more than 100 countries, a rich and ever‐evolving portfolio of pharmaceuticals, biologics, medical devices and over‐the‐counter consumer products, and state‐of‐the‐art resources in R&D, manufacturing and safety surveillance that help millions of patients see more clearly, move more freely and express themselves more fully. From our beginnings as an eye care company to our focus today on several medical specialties, including eye care, neurosciences, medical aesthetics, medical dermatology, breast aesthetics, obesity intervention and urologics, Allergan is proud to celebrate more than 60 years of medical advances and proud to support the patients and physicians who rely on our products and the employees and communities in which we live and work.

Forward‐Looking Statement

This press release contains "forward‐looking statements", including but not limited to the statements by Mr Paul Navarre and Mr David Eccleston and other statements regarding the use of BOTOX® to treat Crow's Feet Lines. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or unknown risks or uncertainties materialise, actual results could vary materially from Allergan's expectations and projections. Risks and uncertainties include, among other things, general industry and pharmaceutical market conditions; technological advances and patents attained by competitors; challenges inherent in the research and development and regulatory processes; challenges related to new product marketing, such as the unpredictability of market acceptance for new pharmaceutical products and/or the acceptance of new indications for such products; inconsistency of treatment results among patients; potential difficulties in manufacturing a new product; general economic conditions; and governmental laws and regulations affecting domestic and foreign operations.  Allergan expressly disclaims any intent or obligation to update these forward-looking statements except as required to do so by law. Additional information concerning these and other risk factors can be found in press releases issued by Allergan, as well as Allergan's public periodic filings with the U.S. Securities and Exchange Commission, including the discussion under the heading "Risk Factors" in Allergan's 2012 Annual Report on Form 10-K and subsequent Quarterly Reports on Form 10-Q.  

© Allergan, Ltd. BOTOX® is a registered trademark owned by Allergan Inc.

References

1. UK SmPC for BOTOX® 50 Units

2. Stotland MA et al. J Plas Recons Surg: 2007; 120(5):1386-1393

3. Allergan Data On File

More Stories By PR Newswire

Copyright © 2007 PR Newswire. All rights reserved. Republication or redistribution of PRNewswire content is expressly prohibited without the prior written consent of PRNewswire. PRNewswire shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon.

Latest Stories
Smart Cities are here to stay, but for their promise to be delivered, the data they produce must not be put in new siloes. In his session at @ThingsExpo, Mathias Herberts, Co-founder and CTO of Cityzen Data, will deep dive into best practices that will ensure a successful smart city journey.
19th Cloud Expo, taking place November 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA, will feature technical sessions from a rock star conference faculty and the leading industry players in the world. Cloud computing is now being embraced by a majority of enterprises of all sizes. Yesterday's debate about public vs. private has transformed into the reality of hybrid cloud: a recent survey shows that 74% of enterprises have a hybrid cloud strategy. Meanwhile, 94% of enterpri...
Why do your mobile transformations need to happen today? Mobile is the strategy that enterprise transformation centers on to drive customer engagement. In his general session at @ThingsExpo, Roger Woods, Director, Mobile Product & Strategy – Adobe Marketing Cloud, covered key IoT and mobile trends that are forcing mobile transformation, key components of a solid mobile strategy and explored how brands are effectively driving mobile change throughout the enterprise.
Businesses are struggling to manage the information flow and interactions between all of these new devices and things jumping on their network, and the apps and IT systems they control. The data businesses gather is only helpful if they can do something with it. In his session at @ThingsExpo, Chris Witeck, Principal Technology Strategist at Citrix, will discuss how different the impact of IoT will be for large businesses, expanding how IoT will allow large organizations to make their legacy ap...
From wearable activity trackers to fantasy e-sports, data and technology are transforming the way athletes train for the game and fans engage with their teams. In his session at @ThingsExpo, will present key data findings from leading sports organizations San Francisco 49ers, Orlando Magic NBA team. By utilizing data analytics these sports orgs have recognized new revenue streams, doubled its fan base and streamlined costs at its stadiums. John Paul is the CEO and Founder of VenueNext. Prior ...
“We're a global managed hosting provider. Our core customer set is a U.S.-based customer that is looking to go global,” explained Adam Rogers, Managing Director at ANEXIA, in this SYS-CON.tv interview at 18th Cloud Expo, held June 7-9, 2016, at the Javits Center in New York City, NY.
Apache Hadoop is a key technology for gaining business insights from your Big Data, but the penetration into enterprises is shockingly low. In fact, Apache Hadoop and Big Data proponents recognize that this technology has not yet achieved its game-changing business potential. In his session at 19th Cloud Expo, John Mertic, director of program management for ODPi at The Linux Foundation, will explain why this is, how we can work together as an open data community to increase adoption, and the i...
"We have several customers now running private clouds. They're not as large as they should be but it's getting there. The adoption challenge has been pretty simple. Look at the world today of virtualization vs cloud," stated Nara Rajagopalan, CEO of Accelerite, in this SYS-CON.tv interview at 18th Cloud Expo, held June 7-9, 2016, at the Javits Center in New York City, NY.
Internet of @ThingsExpo, taking place November 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA, is co-located with 19th Cloud Expo and will feature technical sessions from a rock star conference faculty and the leading industry players in the world. The Internet of Things (IoT) is the most profound change in personal and enterprise IT since the creation of the Worldwide Web more than 20 years ago. All major researchers estimate there will be tens of billions devices - comp...
Developing software for the Internet of Things (IoT) comes with its own set of challenges. Security, privacy, and unified standards are a few key issues. In addition, each IoT product is comprised of (at least) three separate application components: the software embedded in the device, the back-end service, and the mobile application for the end user’s controls. Each component is developed by a different team, using different technologies and practices, and deployed to a different stack/target –...
What does it look like when you have access to cloud infrastructure and platform under the same roof? Let’s talk about the different layers of Technology as a Service: who cares, what runs where, and how does it all fit together. In his session at 18th Cloud Expo, Phil Jackson, Lead Technology Evangelist at SoftLayer, an IBM company, spoke about the picture being painted by IBM Cloud and how the tools being crafted can help fill the gaps in your IT infrastructure.
One of biggest questions about Big Data is “How do we harness all that information for business use quickly and effectively?” Geographic Information Systems (GIS) or spatial technology is about more than making maps, but adding critical context and meaning to data of all types, coming from all different channels – even sensors. In his session at @ThingsExpo, William (Bill) Meehan, director of utility solutions for Esri, will take a closer look at the current state of spatial technology and ar...
According to Forrester Research, every business will become either a digital predator or digital prey by 2020. To avoid demise, organizations must rapidly create new sources of value in their end-to-end customer experiences. True digital predators also must break down information and process silos and extend digital transformation initiatives to empower employees with the digital resources needed to win, serve, and retain customers.
A strange thing is happening along the way to the Internet of Things, namely far too many devices to work with and manage. It has become clear that we'll need much higher efficiency user experiences that can allow us to more easily and scalably work with the thousands of devices that will soon be in each of our lives. Enter the conversational interface revolution, combining bots we can literally talk with, gesture to, and even direct with our thoughts, with embedded artificial intelligence, wh...
Ask someone to architect an Internet of Things (IoT) solution and you are guaranteed to see a reference to the cloud. This would lead you to believe that IoT requires the cloud to exist. However, there are many IoT use cases where the cloud is not feasible or desirable. In his session at @ThingsExpo, Dave McCarthy, Director of Products at Bsquare Corporation, will discuss the strategies that exist to extend intelligence directly to IoT devices and sensors, freeing them from the constraints of ...