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UCB receives CHMP recommendation for approval of new epilepsy drug
UCB has announced that its new epilepsy therapy brivaracetam has been recommended for European regulatory approval.
The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for brivaracetam as an adjunctive therapy for adult epilepsy patients with uncontrolled partial-onset seizures.
Data from phase III clinical trials has shown that brivaracetam significantly reduced the frequency of seizures among patients in this group, with information from these studies supporting the CHMP's decision.
Brivaracetam is also currently under review in other countries including the US, Australia, Canada and Switzerland. If approved in Europe, it will be marketed under the brand name Briviact.
Jean-Christophe Tellier, chief executive officer of UCB, said: "We look forward to the European Commission's decision, and are hopeful that we are able to make brivaracetam available to patients as soon as possible to help improve the lives of those with epilepsy."
Brivaracetam can be initiated without titration, meaning patients can receive a therapeutic dose of the drug from the first day of treatment.
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