Eisai has received recommendations from the European Medicines Agency (EMA) for two of its portfolio of anti-epilepsy drugs (AEDs).

The EMA’s Committee for Medicinal Products for Human Use (CHMP) has recommended extending the use of Zonegran (zonisamide) to a monotherapy for partial seizures in adults with newly diagnosed epilepsy.

It has also recommended the use of Fycompa (perampanel) as an adjunctive treatment of partial-onset seizures in patients with epilepsy aged 12 or older.

Epilepsy is a chronic brain disorder that affects an estimated six million people in Europe, and AEDs are a major strategic focus for Eisai in this market.

The recommendation of Zonegran as a monotherapy is important because patients with newly diagnosed epilepsy find combination therapies particularly difficult to tolerate.

Michel Baulac, Head of the Clinical Department at the Hospital de la Pitie-Salpetriere, Paris, France, said: “Monotherapy remains the optimal approach for managing patients with epilepsy. In addition to a good tolerability profile and to the absence of interaction with other drugs, in particular with oral contraceptives, zonisamide offers the added value of a once-daily dosing.”

Fycompa is a new option for the management of partial-onset epilepsy, as it selectively blocks a particular type of seizure-inducing neurotransmission.

“Improving seizure control is one of the most pressing unmet needs in epilepsy patients,” commented Professor Bernhard Steinhoff, Medical Director of the Epilepsy Center at Kehl-Kork, Germany. “Perampanel will be a completely new option for the adjunctive treatment of patients with uncontrolled seizures.”

NICE has updated its clinical guidelines on the diagnosis and management of epilepsy to incorporate a host of anti-epileptic drugs (AEDs) that have emerged in the UK.

The latest advice specifies different options that doctors should prescribe in accordance with their patient’s type of seizure and epilepsy syndrome and includes choosing which AED to offer on the basis of the presenting syndrome or on the presenting seizure type.

Dr Fergus Macbeth, Director of the Centre for Clinical Practice at NICE, says the guidelines have been updated to ensure healthcare professionals “are prescribing the most clinically and cost effective treatments for their patients”.

The likes of gabapentin, lamotrigine, levetiracetam, oxcarbazepine, tigabine, topiramate and viagabatrin have been launched in the UK since the original guideline was published in 2004.

Doctors are now advised that when prescribing sodium valproate to women and girls of present and future childbearing potential, they should discuss possible risks to unborn children, particularly when using high doses of the AED or when using as part of polytherapy.

NICE also recommends that buccal midazolam or rectal diazepam is only prescribed for children, youngsters and adults who have previously had an episode of prolonged or serial convulsive seizures.

Finally, doctors are advised to administer buccal midazolam as a first-line treatment in children, young people and adults with prolonged or repeated seizures– although rectal diazepam can be administered if preferred, or if buccal midazolam is not available. Intravenous lorazepam may also be used if intravenous access has been established and resuscitation facilities are on-hand.

Professor Helen Cross, who helped develop the guidance on the behalf of NICE, said that the new advice may reduce the time patients with epilepsy spend trying to find a treatment which helps control their condition.

“The update to the guidance outlines how and when doctors should consider treatment for different types of epilepsy, taking into consideration the newer anti-epileptic drugs alongside the more established medicines,” said Professor Cross. “We hope that this will enable doctors to continue to provide the best possible care for individuals with epilepsy.”

Between 260,000 and 416,000 people in the England and Wales are believed to suffer from epilepsy. Around two-thirds of these can effectively control their seizures with AEDs.