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EUROPEAN MEDICINES AGENCY

SCIENCE MEDICINES HEALTH

EMA/796393/2015

EMEA/H/C/003898

EPAR summary for the public

Briviact

brivaracetam

This is a summary of the European public assessment report (EPAR) for Briviact. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Briviact.

For practical information about using Briviact, patients should read the package leaflet or contact their doctor or pharmacist.

What is Briviact and what is it used for?

Briviact is an epilepsy medicine used as an add-on to other epilepsy medicines to treat partial-onset seizures (epileptic fits starting in one specific part of the brain). It can be used in adults and adolescents from the age of 16 years with partial-onset seizures with or without secondary generalisation (where the abnormal electrical activity spreads through the brain).

Briviact contains the active substance brivaracetam.

How is Briviact used?

Briviact is available as tablets (10, 25, 50, 75 and 100 mg), an oral solution (10 mg/ml) and a solution for injection or infusion (drip) into a vein (10 mg/ml). The recommended starting dose is either 25 mg twice a day or 50 mg twice a day, depending on the patient's condition. The dose can then be adjusted according to the patient's needs up to a maximum of 100 mg twice a day.

Briviact can be given by injection or by infusion (drip) into a vein if it cannot be given by mouth.

For further information, see the package leaflet.

The medicine can only be obtained with a prescription.

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© European Medicines Agency, 2016. Reproduction is authorised provided the source is acknowledged.

How does Briviact work?

The active substance in Briviact, brivaracetam, is an epilepsy medicine. Epilepsy is caused by excessive electrical activity in certain areas of the brain. The exact way in which brivaracetam works is not clear but it attaches to a protein called synaptic vesicle protein 2A, which is involved in the release of chemical messengers from nerve cells. This helps Briviact to stabilise electrical activity in the brain and prevent seizures.

What benefits of Briviact have been shown in studies?

Briviact is more effective than placebo (a dummy treatment) at reducing seizures. This was shown in three main studies involving a total of 1,558 patients aged 16 years and above. Either Briviact or placebo was added to patients' usual epilepsy treatment. Taking the studies together, the frequency of seizures was at least halved in 34 to 38% of those adding Briviact at doses from 25 to 100 mg twice a day. This compares with 20% in those adding placebo.

What are the risks associated with Briviact?

The most common side effects with Briviact (which may affect more than 1 in 10 people) are somnolence (sleepiness) and dizziness. For the full list of all side effects reported with Briviact, see the package leaflet.

Briviact must not be used in patients who are hypersensitive (allergic) to brivaracetam, to other pyrrolidone derivatives (substances that are chemically similar to brivaracetam), or to any of the other ingredients.

Why is Briviact approved?

The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Briviact's benefits are greater than its risks and recommended that it be approved for use in the EU.

Clinical studies have shown add-on treatment with Briviact to be more effective than placebo for controlling partial-onset seizures in adults and adolescents from 16 years of age. Most side effects of Briviact were of mild or moderate severity and were considered manageable.

What measures are being taken to ensure the safe and effective use of Briviact?

A risk management plan has been developed to ensure that Briviact is used as safely as possible.

Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Briviact, including the appropriate precautions to be followed by healthcare professionals and patients.

Further information can be found in the summary of the risk management plan.

Other information about Briviact

The European Commission granted a marketing authorisation valid throughout the European Union for Briviact on 14 January 2016.

The full EPAR and risk management plan summary for Briviact can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports. For more

Briviact

EMA/796393/2015    Page 2/3 information about treatment with Briviact, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

This summary was last updated in 01-2016.

Briviact

EMA/796393/2015