Healthcare Industry News:  Ipsen 

Biopharmaceuticals FDA

 News Release - August 1, 2016

Ipsen Biopharmaceuticals, Inc. Announces FDA Approval of Dysport(R) (Abobotulinumtoxin A) for the Treatment of Lower Limb Spasticity in Pediatric Patients Aged Two and Older

BASKING RIDGE, N.J., Aug. 1, 2016 -- (Healthcare Sales & Marketing Network) -- Ipsen Biopharmaceuticals, Inc., a subsidiary of Ipsen SA (Euronext: IPN; ADR: IPSEY) (Ipsen), today announced that the U.S. Food and Drug Administration (FDA) has approved its supplemental Biologics License Application (sBLA) for Dysport® (abobotulinumtoxinA) for injection for the treatment of lower limb spasticity in pediatric patients two years of age and older. Dysport® is the first and only FDA-approved botulinum toxin for the treatment of pediatric lower limb spasticity. Those treated with Dysport® showed statistically significant improvement in co-primary efficacy assessments: mean change from baseline in Modified Ashworth scale (MAS) in ankle plantar flexor muscle tone and mean Physician's Global Assessment (PGA) response to treatment score at Week 4 and Week 12. A majority of patients in the clinical study were eligible for retreatment between 16 and 22 weeks; however, some had a longer duration of response. This approval is based on a randomized, multicenter, double-blind, placebo-controlled, international Phase III pivotal study in 235 pediatric patients (158 received Dysport® and 77 received placebo) aged 2 to 17 years with lower limb spasticity due to cerebral palsy causing dynamic equinus foot deformity.

"Pediatric lower limb spasticity is a neurological condition that is commonly seen in children with cerebral palsy, which affects the communication between the brain and the muscles, resulting in movement and posture problems," said Cynthia Schwalm, Chief Executive Officer, Ipsen Biopharmaceuticals, Inc. "Dysport® is the first and only FDA-approved botulinum toxin for the treatment of pediatric lower limb spasticity. Ipsen is committed to providing patients, their caregivers and their physicians with a comprehensive support offering, including Dysport®, the Ipsen CARES™ patient assistance program, and the C.L.I.M.B.® injector training platform for healthcare providers."

Dysport® and all botulinum toxin products have a Boxed Warning which states that the effects of the botulinum toxin may spread from the area of injection to other areas of the body, causing symptoms similar to those of botulism. Those symptoms include swallowing and breathing difficulties that can be life-threatening. Dysport® is contraindicated in patients with known hypersensitivity to any botulinum toxin preparation or to any of the components; or in the presence of infection at the proposed injection site(s); or in patients known to be allergic to cow's milk protein. The potency Units of Dysport® are specific to the preparation and assay method utilized. They are not interchangeable with other preparations of botulinum toxin products. Please see below for additional Important Safety Information.

"This approval means that, for the first time, physicians have a FDA-approved botulinum toxin with recommended dosing guidance for the treatment of children two years of age and older with lower limb spasticity based on a large registrational study," said Ann Tilton M.D., Professor of Clinical Neurology, Chief, Section of Child Neurology, Louisiana State University School of Medicine.

"United Cerebral Palsy (UCP) is honored to work with responsible companies, like Ipsen, to help meet the needs of people with challenging conditions such as cerebral palsy," said Gloria Johnson-Cusack, Board Chair, United Cerebral Palsy. "Lower Iimb spasticity in pediatric patients with cerebral palsy represents a significant unmet treatment need, as there have been no FDA-approved botulinum toxin treatment options available until now. It is our hope that the work of Ipsen in this area will benefit many individual pediatric patients who struggle with lower limb spasticity."

About Pediatric Lower Limb Spasticity

Spasticity is a condition in which there is an abnormal increase in muscle tone or stiffness in one or more muscles, which might interfere with movement. Spasticity is usually caused by damage to nerve pathways in the brain or spinal cord that control muscle movement, and may occur in association with cerebral palsy, spinal cord injury, multiple sclerosis, stroke, and brain or head trauma.2

Lower limb spasticity commonly involves spasticity in the gastrocnemius and soleus muscle complex located in the calf.1,3 These calf muscles, during walking, work to raise the heel from the ground.1


Source: Ipsen Biopharmaceuticals

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