Source: Ipsen Biopharmaceuticals, Inc. & reported by http://www.prnewswire.com/
BASKING RIDGE, N.J., Aug. 1, 2016 /PRNewswire/ -- 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."
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