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UCB wins European approval for epilepsy drug Briviact

Plans first launches within weeks
UCB

UCB has been granted approval in the EU for Briviact, a new epilepsy drug, and says it plans to start launches of the drug before the end of March.

Briviact (brivaracetam) will provide a new treatment option for the third of epilepsy patients who suffer seizures despite current medications, according to UCB, which notes there are around seven million epilepsy patients in Europe.

The drug has been approved by the European Commission as an adjunctive therapy for partial-onset seizures - with or without secondary generalisation - in people aged 16 and above. In trials, brivaracetam significantly reduced the frequency of seizures compared to placebo, with a 50% reduction in seizures seen in up to 40% of patients treated with UCB's drug.

The drug adds to an epilepsy treatment portfolio at UCB currently represented by Vimpat (lacosamide) - with sales of €495m in the first nine months of 2015 - along with Keppra (levetiracetam) which brought in €565m in the same period despite losing patent protection in most major markets.

Unlike many current epilepsy treatments brivaracetam does not require dose titration, so patients can get a full therapeutic dose to help control seizures from day one, according to UCB.

"There is an unmet need for epilepsy medicines that effectively control seizures and are also well tolerated by patients," said Dr Manuel Toledo, an epilepsy specialist at the Vall d'Hebron Hospital in Barcelona who was involved in the Briviact trials programme.

"A new treatment … that enables patients to receive a therapeutic dose from the very first day without titration, represents a big step forward to further helping people with epilepsy," he added.

The new drug binds to synaptic vesicle protein 2A, which is also targeted by levetiracetam so is a well-established treatment target in epilepsy. It will be launched in three formulations - film-coated tablets, oral solution and an injectable/infusion solution.

Briviact was submitted for approval in the US in January 2015 but remains under review by the FDA.

Article by
Phil Taylor

20th January 2016

From: Regulatory

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