FDA approves extension for Vimpat for partial-onset seizures in pediatric patients.- UCB.

The FDA has approved a label extension for the company's anti-epileptic drug (AED) Vimpat (lacosamide), from UCB, as an oral option for the treatment of partial-onset seizures (POS) in pediatric patients four years and older. This new approval provides clinicians with the option to prescribe Vimpat to their pediatric patients either as an oral solution or a convenient tablet. This allows for flexible administration options, an important consideration when treating children. As the safety of Vimpat injection has not been established in pediatric patients, Vimpat injection is indicated for the treatment of partial-onset seizures only in adult patients (17 years of age and older).

The expanded FDA indication for VIMPAT 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. Adverse reactions in pediatric patients are similar to those seen in adult patients.1 This principle of extrapolating clinical data from well controlled studies in adults has been recognized by the FDA as potentially addressing the challenge of limited pediatric data availability.