FDA expands approval of Vimpat as adjunctive therapy to children in primary generalized tonic-clonic seizures.- UCB

UCB announced that the FDA has approved Vimpat (lacosamide) CV as adjunctive therapy in the treatment of primary generalized tonic-clonic seizures (PGTCS) in patients four years of age and older and Vimpat injection for intravenous use in children four years of age and older. PGTCS is a type of seizure that occurs all over the brain, affecting both sides of the brain from the start, causing muscles to stiffen and convulsions to occur for up to a few minutes.The PGTCS approval is based, in part, on results of a Phase III study recently published in the Journal of Neurology, Neurosurgery & Psychiatry. Adjunctive treatment with Vimpat resulted in a significantly lower risk of developing a second PGTCS during the 24-week treatment period, with the corresponding risk reduction being 45% (p=0.001), and a significantly higher rate of freedom from PGTCS during the treatment period compared with placebo (31.3% vs 17.2%, p=0.011). Results from the Phase III study showed that Vimpat was generally tolerated in patients with Idiopathic Generalized Epilepsy (IGE) and PGTCS. The most common adverse reactions (at least 10%) reported in patients treated with Vimpat were dizziness (23%), somnolence (17%), headache (14%), and nausea (10%) compared to 7%, 14%, 10%, and 6%, respectively, of patients who received placebo. Regarding the expanded pediatric population, Vimpat tablets and oral solution were already approved to treat partial-onset seizures in adults and children four years and older as monotherapy and adjunctive therapy. Vimpat injection was previously approved for the treatment of partial-onset seizures only in adult patients (17 years of age and older). See- Vossler DG , et al. "Efficacy and safety of adjunctive lacosamide in the treatment of primary generalised tonic-clonic seizures: a double-blind, randomised, placebo-controlled trial". J Neurol Neurosurg Psychiatry 2020;0:1–9. doi:10.1136/jnnp-2020-323524 .