MHRA expands approval of Dysport for symptomatic treatment of focal spasticity of the upper limbs in paediatric cerebral palsy
pharmafile | January 6, 2020 | News story | Sales and Marketing | Dysport, MHRA, ipsen, pharma
Ipsen has secured an expansion in the UK to the existing label for Dysport (lemborexant), with the Medicines and Healthcare Products Regulatory Agency (MHRA) awarding licensing approval for the drug in the symptomatic treatment of focal spasticity of the upper limbs in paediatric cerebral palsy (CP) patients of at least two years of age.
The decision was reached on the back of Phase 3 data which illustrated Dysport’s ability to reduce symptom severity according to the Modified Ashworth Scale (MAS) in CP patients treated for upper limb spasticity, while its safety profile was found to be in line with previous approved indications.
CP is estimated to affect around 17 million worldwide, and around one in every 400 babies born in the UK with around 75-91% of these affected with spastic CP.
“Therapeutic options such as botulinum toxin type A are an important part of the multidisciplinary approach for treating spasticity,” explained Alison Smith, Consultant Paediatric Neuro-physiotherapist at NPP Neuro Group. “They work by interrupting the muscle contraction and thereby reducing stiffness related to spasticity helping children with cerebral palsy to not only improve physical functioning but also achieve their goals which can improve their mental and emotional wellbeing. Having a therapeutic option approved for both upper and lower limb indications creates a real benefit for the patient as it allows a holistic treatment approach for any patients with multi-focal spasticity.”
Asad Mohsin Ali, UK & Ireland General Manager, Ipsen 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 in the UK to have obtained this approval that may help children lead as normal a life as possible.”
Matt Fellows
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