MARLOW, England, October 23, 2013 /PRNewswire/ --
Positive Opinion Paves the Way for a Second Aesthetic Indication for VISTABEL® in 29 European Countries
Today, Allergan Inc. announced that VISTABEL® has received a Positive Opinion from the Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM) 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. This is an important step towards securing national licences in the 27 countries of the European Union as well as Norway and Iceland. This Positive Opinion follows the recent authorisation for a similar indication by the U.S. Food and Drug Administration (FDA). The Positive Opinion 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.
"At Allergan, we have a long-term commitment to innovation in neuromodulator research, and this Positive Opinion is testament to this," said Paul Navarre, President of Allergan EAME. "This is an important milestone for Allergan, extending our commitment to support medical aesthetics practitioners by delivering the scientific evidence, the appropriate country licences to promote the drug and the educational training programs to yield the best possible outcomes for patients."
The European Positive Opinion for the use of VISTABEL®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. These studies met their primary endpoint, demonstrating that patients who received treatment with VISTABEL® 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 lasting an average of four months post-treatment. Patients treated with VISTABEL® reported that they looked younger and more attractive. In these studies, Allergan's botulinum toxin type A product was generally well tolerated. 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.
"Crow's Feet Lines are amongst the top ageing concerns for people in 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 Dr. Koenraad de Boulle, Dermatologist and a key investigator in the registration trials. "I'm pleased Allergan invested in the additional research to demonstrate that treatment with VISTABEL® can deliver a refreshed look by softening the appearance of Crow's Feet Lines as well as the glabellar lines."
Notes to Editor
VISTABEL® (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. VISTABEL® should only be administered in a clinical setting by 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.
About the Mutual Recognition Procedure
For VISTABEL®, France serves as the Reference Member State in the Mutual Recognition Procedure. Following the Positive Opinion from Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM), the healthcare regulatory agencies in the 27 countries of the European Union as well as Norway and Iceland will finalise the relevant national licences.
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.
This press release contains "forward‐looking statements", including but not limited to the statements by Mr Paul Navarre and Dr Koenraad de Boulle and other statements regarding the use of VISTABEL® 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. VISTABEL® and VISTABEX® are registered trademarks owned by Allergan, Inc.
- Allergan Data on file - Draft SMPC for VISTABEL® 50 Units
- Allergan Data On file