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Merz North America Announces FDA Approval of Xeomin (incobotulinumtoxinA) for Treatment of Adult Upper Limb Spasticity

RALEIGH, N.C.- December 23, 2015 --Merz North America, U.S. affiliate of the global Merz Pharma Group, announces that Xeomin (incobotulinumtoxinA) has received U.S. FDA approval for the treatment of upper limb spasticity (ULS) in adult patients. In clinical studies, treatment with Xeomin (incobotulinumtoxinA) for adult ULS resulted in statistically and clinically significant improvements in muscle tone, with a safety profile similar to that observed for other Xeomin (incobotulinumtoxinA) indications.

“We know that each patient has unique needs, and this new indication for Xeomin (incobotulinumtoxinA) is a result of our long-term commitment to serving individuals living with movement disorders and spasticity,“ said Glenn Block, Vice President and Head – US Neurosciences for Merz North America. “We look forward to supporting the launch of Xeomin for adult upper-limb spasticity with forward-thinking strategies in product support, clinical education, and patient advocacy and engagement.“

Xeomin (incobotulinumtoxinA) was first approved by the U.S. FDA in August 2010 for the treatment of adults with cervical dystonia and blepharospasm. Today, Xeomin (incobotulinumtoxinA) is available in 43 countries across the globe. Over one million patients worldwide have been treated with Xeomin® (incobotulinumtoxinA)1.

“In multiple well-controlled clinical trials, treatment of adult ULS with Xeomin (incobotulinumtoxinA) resulted in significant improvements in muscle tone,“ said David M. Simpson, MD, FAAN, Professor of Neurology at The Icahn School of Medicine at Mount Sinai, Department of Neurology. “The addition of this effective treatment option for adult ULS means that U.S. physicians now have greater flexibility in selecting a neurotoxin therapy that meets the needs of their individual patients.”

Dr. David M. Simpson is Director of the Neuromuscular Diseases Division and Clinical Neurophysiology Laboratories at The Icahn School of Medicine at Mount Sinai. Dr. Simpson is a member of the American Neurological Association and the American Pain Society. He is a Fellow of the American Academy of Neurology and the American Academy of Neuromuscular and Electrodiagnostic Medicine.

“Merz North America remains dedicated to pursuing strategic, targeted research and development programs in the neurosciences space, with the ultimate goal of providing meaningful treatment options for movement disorder and spasticity patients,“ said David Dobrowski, Vice President and Head of Research and Development for Merz North America.

The safety and efficacy of Xeomin (incobotulinumtoxinA) in the treatment of adult upper limb spasticity was evaluated in multiple Phase III clinical studies in more than 400 patients with ULS. The approval of Xeomin (incobotulinumtoxinA) for the treatment of adult ULS is based on results of a randomized, multicenter, placebo-controlled trial showing significant improvements in two co-primary outcome parameters: muscle tone (Ashworth Scale score) and the Investigator’s Global Impression of Change of the Primary Target Clinical Pattern (PTCP) at Week 4. Both showed statistical significance, with p < 0.001 and p = 0.003 respectively. The trial also met a key secondary outcome measure, in which subjects with an improvement ≥1 on the Ashworth Scale at Week 4 were classified as responders (p<0.001). Treatment related adverse events were reported for 3.8% and 1.9% of subjects treated with Xeomin® (incobotulinumtoxinA) and placebo, respectively. The most commonly observed adverse reactions (incidence ≥2% of patients and greater than placebo) for Xeomin® were seizure (3%), nasopharyngitis (2%), dry mouth (2%), and upper respiratory tract infection (2%).

About Xeomin (incobotulinumtoxinA)

Xeomin (incobotulinumtoxinA) is a prescription medicine that is injected into muscles and used to treat increased muscle stiffness in the arm of adults with upper limb spasticity, the abnormal head position and neck pain that happens with cervical dystonia (CD) in adults, and to treat abnormal spasm of the eyelids (blepharospasm) in adults who have had prior treatment with onabotulinumtoxinA (Botox®).

About Merz Neurosciences

Merz Neurosciences is a division of Merz North America, a specialty healthcare company that is dedicated to delivering a better total experience in aesthetics, dermatology and neurosciences. By working side by side with physicians and patients, Merz Neurosciences strives to deliver meaningful treatment options and a better patient experience in order to meet the needs of each person we serve. Merz Neurosciences is an important contributor to the U.S. neurosciences space, offering a well-balanced product portfolio that includes the neurotoxin Xeomin® (incobotulinumtoxinA), the anticholinergic Cuvposa™ (glycopyrrolate) Oral Solution and the Prolaryn™ family of products.

To learn more about Merz Neurosciences and their U.S. product portfolio, please visit www.merzusa.com/neurosciences.

Source: Merz North America, U.S.

Posted: December 2015

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