July 20, 2015
Ipsen Biopharmaceuticals has received approval from the US Food and Drug Administration (FDA) for its supplemental Biologics License Application (sBLA) for Dysport (abobotulinumtoxinA) to treat upper limb spasticity (ULS) in adult patients.
Dysport is now approved to treat ULS in adults to decrease the severity of increased muscle tone in elbow flexors, wrist flexors and finger flexors.
The company said that clinical improvement may be expected one week after administration of Dysport.
A majority of patients in clinical trials were retreated between 12 and 16 weeks; some patients had a duration of response as long as 20 weeks.
The approval was based on a clinical trials conducted in more than 600 patients.
In the Phase III pivotal trial, a total of 238 adult patients with upper limb spasticity participated in the study for up to one year.
The international, multi-center, double-blind, randomized, placebo-controlled trial compared the efficacy of Dysport versus placebo in hemiparetic patients following stroke or brain trauma.
The study also included patients who were botulinum toxin naïve or previously treated with a botulinum toxin, encompassing a broad patient population.
The Dysport Phase III trial was the first registration study to evaluate ULS treatment in adults with both stroke and traumatic brain injury.
Ipsen Biopharmaceuticals CEO Cynthia Schwalm said: “It is estimated that 1.8 million adult Americans may suffer from spasticity1234, which in the upper arm can cause muscle stiffness, flexing, spasms, twitching and pain.
“We are pleased to offer another treatment option for those individuals with upper limb spasticity, a debilitating condition that often comes on the heels of a traumatic health event such as a stroke or brain injury.
“Spasticity can have a profound impact on adult patients and their abilities to perform the most basic daily tasks. Ipsen is committed to providing these patients, their caregivers and 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.”
Data from the Phase III trial showed that those treated with Dysport demonstrated statistically significant improvement in muscle tone measured by the MAS and a significantly higher physician-rated clinical benefit measured by the PGA versus placebo at Week 4.
Staff Writer, Pharmaceutical Business Review