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.
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.
This Week's Must Reads
Must Reads in FDA Actions
FDA Approves Firdapse for Rare Autoimmune Disorder, FDA news release; 2018 Nov 28
FDA Approves Ajovy for Migraine in Adults, Teva Pharmaceutical news release; 2018 Sep 14
FDA Approves Tiglutik for Treatment of ALS, ITF Pharma news release; 2018 Sep 6
FDA Approves Diacomit for Treatment of Seizures, Biocodex news release; 2018 Aug 23
FDA Approves Drug for Rare Peripheral Nerve Disease, FDA Web site; 2018 Aug 10