Ipsen's Dysport approved for expanded use by FDA

Ipsen Biopharmaceuticals Inc., an affiliate of Ipsen SA, has had its Dysport injection for treating spasticity in adults approved for expanded use by the U.S. Food and Drug Administration.

“Adult patients who have developed spasticity as a result of a stroke, multiple sclerosis, cerebral palsy, spinal cord injury, or traumatic brain injury now have another option when seeking treatment that helps reduce the effects of the increased muscle tone in their lower extremities,” Dr. Alexandre Lebeaut, executive vice president for Ipsen, said in a statement.

The expanded approval allows the drug to be used to treat lower limb spasticity. This comes after a 2015 approval to treat upper limb spasticity and a 2016 approval to treat lower limb spasticity in pediatric patients.

“Dysport is currently the only botulinum toxin approved by the FDA for the treatment of spasticity in adults in upper and lower limbs and also for the treatment of lower limb spasticity in children ages 2 and older,” Cynthia Schwalm, president of North America Commercial Operations, said. “We are proud that Dysport is now available to support an additional population of patients — including those adults managing their spasticity associated with stroke, brain injury, spinal cord injury, multiple sclerosis, or cerebral palsy —and that Ipsen is able to provide comprehensive support offerings, including the IPSEN CARES patient assistance program and the C.L.I.M.B. injector training platform for health care providers.”