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news.UCB has announced that the European Medicines Agency's Committee for Medicinal Products for Human Use has issued a positive opinion recommending a marketing authorization for lacosamide, proposed trade name Vimpat, for the adjunctive treatment of partial onset seizures with or without secondary generalization in patients with epilepsy, aged 16 years and older.
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The recommendation has been granted for the oral tablet, oral syrup and intravenous formulations.
The Committee for Medicinal Products for Human Use decision is supported by data from three multicentre, double blind, placebo controlled clinical trials that evaluated the efficacy, safety and tolerability of lacosamide (200, 400 and 600mg/day given in two divided doses) in a total of over 1,300 adults with uncontrolled partial onset seizures.
Roch Doliveux, CEO of UCB, said: “The European positive opinion for approval of Vimpat marks a major achievement for patients with epilepsy whose seizures are not well controlled by current antiepileptic drugs, and for UCB, strengthening our leadership in treatments for this severe disease.”