10 July 2020 - Dysport is now FDA approved to treat both upper and lower limb spasticity in paediatric patients two years of age and older, including spasticity caused by cerebral palsy.

Ipsen Biopharmaceuticals announced today that the US FDA has approved the expanded use of Dysport (abobotulinumtoxinA) in pediatric patients. When Dysport was first FDA approved in 2016 for paediatric lower limb spasticity, Ipsen was granted Orphan Drug exclusivity for paediatric patients whose lower limb spasticity was caused by cerebral palsy (CP).

Similarly, in 2019, Dysport received FDA approval for the treatment of upper limb spasticity in children two years of age and older, excluding upper limb spasticity caused by CP, due to Orphan Drug exclusivity granted to another manufacturer.

Ipsen has worked with the FDA and this manufacturer to selectively waive their respective exclusivities to better support patient care. As a result, Dysport is now FDA-approved to treat both upper and lower limb spasticity in paediatric patients two years of age and older, including spasticity caused by cerebral palsy.

Read Ipsen press release