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Merz Aesthetics Announces FDA Approval Of XEOMINŽ
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Jul 21, 2011
Merz Aesthetics Announces FDA Approval Of XEOMINŽ (incobotulinumtoxinA) For The Temporary Improvement In The Appearance Of Moderate To Severe Glabellar Lines In Adult Patients
SAN MATEO, Calif., July 21, 2011 /-- Merz Aesthetics today announced that the United States (U.S.) Food and Drug Administration (FDA) has approved XEOMINŽ (incobotulinumtoxinA) for the temporary improvement in the appearance of moderate to severe glabellar lines, or frown lines between the eyebrows, in adult patients.
"The FDA approval of XEOMIN is a significant milestone for Merz Aesthetics and a promising addition to our entire aesthetics franchise," said Dennis Condon, President and Chief Business Officer of Merz Aesthetics, Inc. "We are confident that XEOMIN will provide patients and physicians with a new option for improving the appearance of glabellar lines."
"XEOMIN is a promising new option for both patients and physicians and we are encouraged by the response rates seen in the Phase III clinical trials," said Derek H. Jones, M.D., an investigator for the XEOMIN U.S. study, Clinical Associate Professor of Medicine at the University of California in Los Angeles, Calif., and Director of Skin Care and Laser Physicians in Beverly Hills, Calif.
The approval of XEOMIN is based on the results of two pivotal U.S. clinical trials involving 16 investigational sites and included 547 healthy adult patients. In both studies, XEOMIN significantly improved the appearance of glabellar lines 30 days following the first injection, when compared to placebo. XEOMIN is the only botulinum toxin currently approved in the U.S. that does not require refrigeration prior to reconstitution.
XEOMIN is approved for the temporary improvement in the appearance of glabellar lines in 14 countries in the European Union (EU), including Germany, the United Kingdom, France, Italy and Spain, under the brand name BOCOUTUREŽ.
XEOMIN will be available nationwide to physicians in the spring of 2012.
INDICATIONS AND USAGE
XEOMIN (incobotulinumtoxinA) is indicated for the temporary improvement in the appearance of moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity in adult patients.
IMPORTANT SAFETY INFORMATION
WARNING: DISTANT SPREAD OF TOXIN EFFECT
See full prescribing information for complete boxed warning.
The effects of XEOMIN and all botulinum toxin products may spread from the area of injection to produce symptoms consistent with botulinum toxin effects. These symptoms have been reported hours to weeks after injection. Swallowing and breathing difficulties can be life threatening and there have been reports of death. The risk of symptoms is probably greatest in children treated for spasticity but symptoms can also occur in adults, particularly in those patients who have underlying conditions that would predispose them to these symptoms.
XEOMIN is contraindicated in patients with a known hypersensitivity to the active substance botulinum toxin type A or to any of the components in the formulation and in the presence of infection at the proposed injection site(s).
WARNINGS AND PRECAUTIONS
The potency units of XEOMIN are not interchangeable with other preparations of botulinum toxin products. Therefore, units of biological activity of XEOMIN cannot be compared to or converted into units of any other botulinum toxin products.
Hypersensitivity reactions have been reported with botulinum toxin products (anaphylaxis, serum sickness, urticaria, soft tissue edema, and dyspnea). If serious and/or immediate hypersensitivity reactions occur further injection of XEOMIN should be discontinued and appropriate medical therapy immediately instituted.
Treatment with XEOMIN and other botulinum toxin products can result in swallowing or breathing difficulties. Patients with pre-existing swallowing or breathing difficulties may be more susceptible to these complications. In most cases, this is a consequence of weakening of muscles in the area of injection that are involved in breathing or swallowing. When distant effects occur, additional respiratory muscles may be involved [See Boxed Warning]. Deaths as a complication of severe dysphagia have been reported after treatment with botulinum toxin. Dysphagia may persist for several months, and require use of a feeding tube to maintain adequate nutrition and hydration. Aspiration may result from severe dysphagia and is a particular risk when treating patients in whom swallowing or respiratory function is already compromised. These reactions can occur within hours to weeks after injection with botulinum toxin.
Glabellar Lines: Do not exceed the recommended dosage and frequency of administration of XEOMIN. In order to reduce the complication of ptosis the following steps should be taken:
Avoid injection near the levator palpebrae superioris, particularly in patients with larger brow depressor complexes.
Corrugator injections should be placed at least 1 cm above the bony supraorbital ridge.
Individuals with peripheral motor neuropathic diseases, amyotrophic lateral sclerosis, or neuromuscular junctional disorders (e.g., myasthenia gravis or Lambert-Eaton syndrome) should be monitored particularly closely when given botulinum toxin. Patients with neuromuscular disorders may be at increased risk of clinically significant effects including severe dysphagia and respiratory compromise from typical doses of XEOMIN.
Glabellar Lines: The most common adverse reaction (incidence greater than or equal to 2% of patients and greater than placebo) for XEOMIN was Headache (5.4%).
Concomitant treatment of XEOMIN and aminoglycoside antibiotics, spectinomycin, or other agents that interfere with neuromuscular transmission (e.g., tubocurarine-like agents), or muscle relaxants, should be observed closely because the effect of XEOMIN may be potentiated.
USE IN PREGNANCY
Pregnancy Category C: There are no adequate and well-controlled studies in pregnant women. XEOMIN should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Please see Full Prescribing Information for more information on XEOMIN including complete Boxed WARNING.
About Merz Aesthetics
Merz Aesthetics, Inc. is a division of Germany-based Merz Pharmaceuticals. Merz Aesthetics, with headquarters in San Mateo, California, operates subsidiaries in 16 countries and cooperates with more than 30 distributors worldwide.
Founded in 1908 by Friedrich Merz, Merz introduced the world's first anti-wrinkle treatment in 1953 after conducting extensive research on the effects of revitalizing skin care essences. As part of the Merz Pharma Group of companies, Merz Aesthetics leverages more than a century of Merz's healthcare expertise with its products and unparalleled service to the field of aesthetic dermatology. The Merz legacy continues today with Merz Aesthetics' innovative portfolio of products.
Merz Aesthetics' product portfolio in the U.S. includes RADIESSEŽ Filler, ASCLERAŽ (polidocanol) Injection and XEOMIN, a botulinum toxin type A for the temporary improvement in the appearance of moderate to severe glabellar lines in adult patients. Outside of the U.S., the Merz Aesthetics' portfolio includes RADIESSEŽ Filler, the BELOTEROŽ family of fillers, and BOCOUTUREŽ.
XEOMIN is a registered trademark of Merz Pharma GmbH & Co. KGaA.
CONTACT: Danielle Lewis, Medical Dynamics, +1-212-537-9495, firstname.lastname@example.org