Ipsen gets FDA approval of Dysport for treatment of Upper Limb Spasticity in children, excluding cerebral palsy

Ipsen got approval for Dysport, the first and only FDA-approved botulinum toxin for treatment of both pediatric upper and lower limb spasticity, as the pivotal Phase 3 study showed Dysport improved spasticity symptoms in children aged two to 17 experiencing upper limb spasticity, as measured by the primary efficacy endpoint of Modified Ashworth Scale at elbow or wrist flexors at Week 6.

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Ipsen Biopharmaceuticals, an affiliate of Ipsen (Euronext: IPN; ADR: IPSEY), announced today that the United States Food and Drug Administration (FDA) has expanded the use of Dysport^® (abobotulinumtoxinA) for injection to include the treatment of upper limb spasticity in children two years of age and older, excluding spasticity caused by cerebral palsy (CP). This approval makes Dysport the first botulinum toxin approved by the FDA for both pediatric spasticity indications, following the previous approval to treat children with lower limb spasticity aged two and older received in July 2016.¹

“For physicians, it is reassuring to have a botulinum toxin treatment in Dysport which demonstrated sustained symptom relief for spasticity, which can be physically challenging for children,” said Ann Tilton, MD, study investigator and Professor of Clinical Neurology at the Louisiana State University Health Sciences Center New Orleans. “This FDA decision for Dysport means we now have an approved therapy to offer children and adolescents seeking improvements in mobility in both upper and lower limbs.”

The approval is based on a Phase 3 study with children aged two to 17 years old being treated for upper limb spasticity.¹ Due to Orphan Drug Exclusivity, this approval excludes use in children with upper limb spasticity caused by CP. Dysport demonstrated statistically significant improvements from baseline at Week 6 with doses of 8 Units/kg and 16 Units/kg vs. 2 Units/kg, as measured by the Modified Ashworth Scale (MAS) in the elbow or wrist flexors.¹ Dysport demonstrated a reduction in spasticity symptoms through 12 weeks for most children for both upper and lower limbs.¹ In the upper limb study, a majority of patients were retreated between 16-28 weeks; however, some patients had a longer duration of response (i.e., 34 weeks or more).¹ The most frequent adverse reactions observed were upper respiratory tract infection and pharyngitis.¹

Dysport and all botulinum toxin products have a Boxed Warning, which states that the effects of the botulinum toxin may spread from the area of injection to other areas of the body, causing symptoms similar to those of botulism.¹ Those symptoms include swallowing and breathing difficulties that can be life-threatening.¹ Dysport is contraindicated in patients with known hypersensitivity to any botulinum toxin preparation or to any of the components; or in the presence of infection at the proposed injection site(s); or in patients known to be allergic to cow’s milk protein.¹ The potency Units of Dysport are specific to the preparation and assay method utilized.¹ They are not interchangeable with other preparations of botulinum toxin products.

“This approval is a testament to Ipsen’s legacy in neurotoxin research and continued commitment to advancing patient care,” said Kimberly Baldwin, Vice President, Franchise Head, Neuroscience Business Unit, Ipsen. “We believe the data for both pediatric upper and lower limb spasticity underscore the role of Dysport as an important treatment option for patients seeking long-lasting spasticity symptom relief.”

Spasticity affects more than an estimated 12 million people worldwide and is a condition in which there is an abnormal increase in muscle tone or stiffness, which may interfere with movement and particularly impacts growing children.^2,3 Treatment with injectable medications, including Dysport, have shown to be effective in relieving the symptoms associated with spasticity in the arms and legs among children.