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UCB receives recommendation for epilepsy drug
UCB has announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has recommended that the European Commission grants a marketing authorisation for Vimpat (lacosamide) for the treatment of partial onset seizures in patients with epilepsy.
The recommendation has been given for the oral syrup and the oral tablet, as well as intravenous formulations.
Roch Doliveux from 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.”
Support for the CHMP’s decision has been provided by three multicentre, double blind, placebo controlled clinical trials that evaluated safety, efficacy and tolerability of the drug.
All of these studies saw more than 50 per cent reductions in median seizure frequency for those taking Vimpat (lacosamide) in comparison to the placebo groups.
Earlier this month, UCB revealed it will be replacing Nepro supply with product that has been refrigerated from manufacture in order to reduce the development of crystals.
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