UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) has granted a licence update for Ipsen’s Dysport.
Dysport is an injectable form of a botulinum neurotoxin type A product now used for treating focal spasticity of upper limbs in pediatric cerebral palsy patients, indicated for use on children aged two years and above.
MHRA decision comes from findings of Phase III study of Dysport involving 210 children aged two to 17 years.
According to Ipsen, administering Dysport reduced spasticity symptoms among the subjects, with data measured by the standard scale for assessing muscle resistance associated with spasticity, Modified Ashworth Scale (MAS).
Ipsen UK & Ireland general manager Asad Mohsin Ali said: “Today’s approval is an important advancement for children in the UK living with cerebral palsy, who can now benefit from long-lasting symptom relief between their botulinum toxin A injections.
“As a father myself, I am proud that Ipsen is the first company to have obtained this approval that may help children live as normal a life as possible.”
Spasticity refers to involuntary muscle stiffness or contractions in a group of muscles. Cerebral palsy (CP) is one of the leading causes of spasticity among children.
In the UK, around one in 400 babies have a type of CP. Around 90% of them will develop spastic cerebral palsy, affecting their motor skills and movement abilities.
Ipsen is a French pharmaceutical company, which primarily develops medicines in oncology, neuroscience and rare disease therapeutic areas.
Last year, the company acquired Canada-based Clementia Pharmaceuticals for nearly $1bn.