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news.Belgium-based biopharmaceutical and specialty chemical company UCB has announced that the European Commission has approved Vimpat as adjunctive therapy in the treatment of partial-onset seizures with or without secondary generalization in patients with epilepsy aged 16 years and older.
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The European Commission approval is based on data from three multicenter, randomized, placebo-controlled clinical trials that evaluated the efficacy and safety of Vimpat adjunctive treatment in over 1,300 partial-onset seizure patients aged 16 years and older who were not adequately controlled with between one to three concomitant antiepileptic drugs (AEDs) and with or without additional vagus nerve stimulation. Patients entering these trials were experiencing on average 10-15 seizures per month and most patients (84%) were uncontrolled on two to three AEDs.
In clinical trials Vimpat improved seizure control when added to a wide range of first and second generation AEDs. Pooled analysis shows that treatment with Vimpat 200mg/day and 400mg/day reduced seizures by half in 34% and 40% of patients with partial-onset seizures, respectively, compared with 23% in the placebo group.
UCB said that Vimpat is the first new AED for partial-onset seizures in three years and offers a new treatment option for European patients living with uncontrolled partial-onset epilepsy.
Roch Doliveux, CEO of UCB, said: “The approval of Vimpat underscores the importance of UCB’s continued drive to develop innovative medicines that improve lives. UCB is pleased to make this important new AED available to European physicians and patients.”