FDA approves first ULS drug in 5 years

FDA approved Ipsen Biopharmaceuticals’ supplemental Biologics License Application (sBLA) for abobotulinumtoxinA (Dysport) for the treatment of upper limb spasticity (ULS).

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Dysport, which decreases the severity of increased muscle tone in elbow flexors, wrist flexors and finger flexors, is the first therapy in the past 5 years that was approved by FDA for the treatment of adults with ULS. In clinical trials, some patients realized improvement within 1 week after administration. A majority of patients in clinical studies were retreated between 12 and 16 weeks; however, some patients had a duration of response as long as 20 weeks.

“It is estimated that 1.8 million adult Americans may suffer from spasticity, which, in the upper arm, can cause muscle stiffness, flexing, spasms, twitching and pain,” said Cynthia Schwalm, CEO of Ipsen Biopharmaceuticals. “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.”

The Dysport phase 3 trial was the first registration study to evaluate ULS treatment in adult patients with both stroke and traumatic brain injury. The drug was previously approved in the United States for the treatment of adults with cervical dystonia (CD) in April, 2009.

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FDA’s approval was based on a rigorous development program that included clinical trials conducted in more than 600 patients. In the phase 3 pivotal study, 238 adult patients with upper limb spasticity participated in the study for up to one year. The international, multicenter, double-blind, randomized, placebo-controlled study compared the efficacy of Dysport versus placebo in hemiparetic patients following stroke or brain trauma.

The study 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.

The trial was followed by an open-label study wherein patients received Dysport for up to 5 treatment cycles to assess the long-term safety. 

The most frequently reported adverse reactions to Dysport are urinary tract infection, nasopharyngitis, muscular weakness, musculoskeletal pain, dizziness, falls and depression.

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