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FDA Approves Dysport for Pediatric Limb Spasticity

Ipsen news release; 2016 Aug 1

The FDA has approved an abobotulinumtoxinA (Dysport) injection for treating children aged ≥2 years who have pediatric lower limb spasticity.

Indications: Dysport, the first and only FDA-approved botulinum toxin for the treatment of pediatric lower limb spasticity, is an injectable form of botulinum toxin type A (BoNT-A), which is isolated and purified from Clostridium bacteria producing BoNT-A. It is supplied as a lyophilized powder.

Dosage/administration: Recommended total Dysport dose per treatment session is 10 to 15 units/kg per limb. Total dose per treatment session must not exceed 15 units/kg for unilateral lower limb injections, 30 units/kg for bilateral injections, or 1,000 units, whichever is lower. Re-treatment, based on return of clinical symptoms, should not occur in intervals of less than 12 weeks.

Adverse reactions: Most common adverse reactions (≥10% in any group and greater than placebo) in pediatric patients with lower limb spasticity for Dysport 10 units/kg, 15 units/kg, 20 units/kg, or 30 units/kg, were upper respiratory tract infection, nasopharyngitis, influenza, pharyngitis, cough, and pyrexia.

Citation:

Ipsen Pharmaceuticals, Inc. announces FDA approval of Dysport (abobotulinumtoxinA) for the treatment of lower limb spasticity in pediatric patients aged 2 and older. [news release]. Basking Ridge, NJ: Ipsen; Aug. 1, 2016: www.ipsen.com. Accessed Aug. 1, 2016.