New epilepsy drug on the horizon
Brivaracetam, an add-on therapy for people over the age of 16 with partial onset seizures, could soon be marketed as Briviact® following a decision by the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) to adopt a 'positive opinion' for the new anti-epileptic drug.
This means that, subject to approval by the European Commission, Briviact will be available as 10 mg, 25 mg, 50 mg, 75 mg and 100 mg film-coated tablets, a 10 mg/ml oral solution, and a 10 mg/ml solution for injection/infusion.
Partial onset seizures
The active substance of Briviact is brivaracetam, whose anticonvulsant activity is believed to be mediated mainly through interference with a protein called synaptic vesicle protein 2A.
CHMP said: 'The benefits with Briviact are its ability to reduce the frequency of partial-onset seizures in epilepsy patients when added to an existing regimen of anti-epileptic medicines. The most common side effects are somnolence, dizziness and fatigue.'
Epilepsy Society's medical director Professor Ley Sander commented: 'It is always good to have new treatment options for epilepsy. The way that people respond to different drugs is very individual and there can be quite a journey before some people with epilepsy find the drug that gives them optimum seizure control with minimum side effects.
'For some people seizure freedom or a reduction in seizure frequency and severity can come at a price with unpleasant side effects. All the signs so far are that brivaracetam is well tolerated and it will be helpful to have another epilepsy drug for people to try.'
People who were trialling brivaracetam showed statistically significant reductions over placebos in partial-onset seizure frequency per 28 days (19.5 per cent, 24.4 per cent and 24 per cent for brivaracetam 50, 100 and 200 mg/day respectively.)
The proportion of patients showing a 50 per cent or greater reduction in partial-onset seizure frequency was 34.2 per cent (50 mg/day), 39.5per cent (100 mg/day) and 37.8per cent (200 mg/day), compared with. 20.3per cent for placebo).
Brivaracetam is also currently under review in other countries including the US, Australia, Canada and Switzerland.
UCB and epilepsy
The new epilepsy drug has been developed by the Belgium based pharmaceutical company UCB whose UK premises are in Slough. Chief executive officer, Jean-Christophe Tellier, said: 'This CHMP positive opinion for brivaracetam represents a significant step forward to providing a new treatment option for epilepsy patients who cannot control their seizures with current antiepileptic drugs.
'Over the years UCB has been building a leading expertise in epilepsy, working very closely with patients through all stages of development to ensure UCB scientists and physicians better understand the unmet needs of those with this severe and complex chronic disease.
'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.'
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