FDA Approves Med to Treat Lower Limb Spasticity
The US Food and Drug Administration (FDA) has approved abobotulinumtoxinA (Dysport) to treat children for lower limb spasticity, according to a company statement.
The approval was based on results from a Phase 3 trial that showed a response that lasted 16 to 22 weeks, according to Ipsen, the drug manufacturer.
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“The approval of abobotulinumtoxinA means that, for the first time in the USA, physicians have an FDA-approved botulinum toxin and recommended dosing and administration guidance for the treatment of children from two years of age and older with lower limb spasticity,” Dr. Mauricio Delgado, the US principal investigator of the Phase 3 trial, said in a statement. “This approval is based on data coming from worldwide studies conducted on several continents. Results were published in the journal Pediatrics confirming that we have conducted a pivotal study in this field.”
The medication, approved for children aged 2 and older, contains a Boxed Warning alerting patients that the toxin can spread in the body. Difficulty swallowing and breathing, with potentially life-threatening implications, can occur.
Ipsen. Ipsen announces FDA approval of Dysport® (abobotulinumtoxinA) for injection for the treatment of lower limb spasticity in children aged two and older [press release]. www.businesswire.com. August 1, 2016.