FDA approves new Dysport indication

SILVER SPRING, Md. — The Food and Drug Administration has approved a new indication for Ipsen Biopharmaceuticals’ Dysport (abobotulinumtoxinA), the company announced Monday. The drug can now be used to treat lower limb spasticity in pediatric patients ages 2 years and older. 

 

"This approval means that, for the first time, physicians have a FDA-approved botulinum toxin with recommended dosing guidance for the treatment of children two years of age and older with lower limb spasticity based on a large registrational study," said Dr. Ann Tilton, professor of clinical neurology and chief of the section of child neurology at Louisiana State University School of Medicine.

 

The drug comes with a boxed warning stating that the effects of the botulinum toxin may spread from the injection area to other areas of the body, causing symptoms akin to those of botulism.