The Scottish Medicines Consortium (SMC) has approved Fycompa (perampanel) for use as an adjunctive treatment in hard to treat cases of epilepsy.

Eisai’s drug is recommended as an additional second-line therapy for partial-onset epilepsy, the most common form of the disease, in people aged 12 and over.

Its approval adds to the armoury of drugs available to treat uncontrolled partial seizures, which have a severe impact on quality of life.

The incidence of uncontrolled partial seizures is high (20–40%) despite the wide range of anti-epileptic drugs available.

The number of people with epilepsy in Scotland has increased by 40% in six years to 54,000, indicating an urgent need for better medical solutions.

Fycompa is a first in class drug: the only licensed AED in Europe that targets the neurological receptors thought to play a central role in seizures. It blocks their response to glutamate, an excitatory neurotransmitter.

In addition, Fycompa has the benefit of convenient, once-daily dosing.

The licensing of the drug by the European Commission was based on three global Phase III studies with 1,480 subjects, which demonstrated its efficacy and tolerability as an adjunctive therapy.

“This approval from the SMC is a positive step in the management of people with epilepsy in Scotland,” said Martin Brodie, Professor of Medicine and Clinical Pharmacology at the University of Glasgow.

“Uncontrolled seizures have a severe impact on everyday function and quality of life and so we look forward to the possibility of being able to offer our epilepsy patients a new treatment option.”

Nick Burgin, Director Market Access, Eisai EMEA & Russia, commented: “This is the first health technology approval in Europe [for Fycompa] and demonstrates the SMC’s commitment to giving patients access to innovative medicines.”

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.”