Oral Vimpat Approved for Use in Pediatric Patients with Partial-Onset Seizures

Tuesday, November 07, 2017 | Epilepsy & Seizure Disorders , FDA Approval/Clearance , Phase 3/4 Trials , Product Launches and Updates


The FDA approved a label extension for Vimpat (lacosamide, UCB) CV as an oral option for the treatment of partial-onset seizures (POS) in pediatric patients four years and older. The expanded indication is based on the principle of extrapolation of its efficacy data from adults to children, and is supported by safety and pharmacokinetics data collected in children, according to the company. Data suggest that adverse reactions to oral Vimpat in pediatric patients are similar to those seen in adult patients.

Vimpat injection has not been established in pediatric patients and is only  indicated for the treatment of partial-onset seizures only in patients 17 years of age and older.

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