Ipsen Biopharmaceuticals, Inc announced that the United States Food and Drug Administration (FDA) has agreed to review the supplemental Biologics License Application (sBLA) for Dysport® (abobotulinumtoxinA) to treat upper limb spasticity, a condition that affects many people in the United States, including multiple sclerosis (MS) patients.
More than 500,000 Americans suffer with spasticity; when it occurs in the upper arm, it can cause muscle stiffness, spasms, flexing and twitching. Spasticity is not a life threatening condition, but it is extremely painful and can compromise the ability to perform everyday tasks such as dressing and taking a bath. It is usually related to strokes, traumatic brain or spinal cord injuries, cerebral palsy and the progressive, debilitating symptoms associated with multiple sclerosis.
The Ipsen Phase III study enrolled more than 250 adults suffering from upper limb spasticity condition. The international study was double-blinded, multi-center, randomized, and controlled with a placebo group, comparing Dysport® and its efficacy in hemiparetic patients following stroke or brain trauma with a placebo in a similar groups of patients. The study found that patients treated with Dysport had muscle tone improvement and more clinical benefits than those treated with the placebo. The safety profiles were positive and consistent for Dysport as well.
Cynthia Schwalm, Ipsen Biopharmaceuticals CEO, said in a press release: “There is more than 20 years of clinical experience worldwide with Dysport® in a variety of neurologic conditions. We are excited at the prospect of being able to bring adult patients who suffer from upper limb spasticity a new treatment option upon an anticipated FDA approval.”
Dysport® was not approved to treat upper limb spasticity in the United States, despite its approval in many other international markets. It is anticipated that it will be made available to treat upper limb spasticity, just as it is to treat cervical dystonia, and that it will improve the lives of millions of people, including multiple sclerosis patients.