EISAI ANNOUNCES EUROPEAN COMMISSION APPROVAL FOR FYCOMPA® (PERAMPANEL) USE IN CHILDREN WITH EPILEPSY

EISAI ANNOUNCES EUROPEAN COMMISSION APPROVAL FOR FYCOMPA^® (PERAMPANEL) USE IN CHILDREN WITH EPILEPSY

• Fycompa^® (perampanel) is now approved for adjunctive treatment of partial-onset seizures with or without secondary generalised seizures in patients from 4 years of age and older, and primary generalised tonic-clonic (PGTC) seizures in patients from 7 years of age and older with idiopathic generalised epilepsy (IGE), providing a new treatment option for children in Europe¹
• Epilepsy affects almost a million children in Europe and up to 20% will still experience uncontrolled seizures despite the currently available anti-epileptic treatments^2,3
• This announcement strengthens Eisai’s commitment to improving the lives of people of all ages with epilepsy, allowing them to be themselves and live the lives they want to with confidence.

HATFIELD, England, 13 November 2020 – The European Commission (EC) has approved expanding the indication of anti-epileptic agent Fycompa (perampanel) to include the treatment of children with epilepsy. Perampanel will now be available as an adjunctive therapy for the treatment of partial-onset seizures (POS) with or without secondary generalised seizures in children from 4 years old and primary generalised tonic-clonic seizures (PGTC) in children from 7 years old with idiopathic generalised epilepsy (IGE).¹

Nearly a million children and adolescents are estimated to have active epilepsy in Europe, with 100,000 new cases diagnosed each year.² Despite currently available treatments, up to 20% of paediatric patients have poorly controlled seizures, placing a burden on their quality of life and that of their family and carers.³

“Eisai is very pleased to be able to provide a new treatment option for children with epilepsy. We hope it will provide better seizure control for the patients that need it, allowing them, and their families, to live the life they want to with confidence,” said Neil West, Vice President EMEA, Global Neurology Business Unit.

The approval was based on the results of two clinical studies, Study 311 (Phase III) and Study 232 (Phase II), conducted globally to evaluate perampanel (oral suspension) as an adjunctive therapy in paediatric patients.^4,5 Study 311 evaluated the safety and tolerability of perampanel when administered as an adjunctive therapy in paediatric patients (age 4 to <12 years) with inadequately controlled partial-onset seizures or generalised tonic-clonic seizures.⁴ Study 232 evaluated the pharmacokinetics, efficacy, and long-term safety of adjunctive perampanel in paediatric patients (from 2 to <12 years of age).⁵

“The day to day impact of uncontrolled epilepsy in children can be very difficult for them to understand and manage, affecting all aspects of their lives from a very young age. Providing new treatment options to children must be done with caution, care and diligence, and I am very happy to have taken part in this study to be able to provide this new treatment option to children, and their families, who are in desperate need of support with their condition,” said Professor András Fogarasi, Head of Neurology at Bethesda Children's Hospital, Budapest and Principal Investigator on Study 311.

It is estimated that there are approximately 6 million patients with epilepsy in Europe, and although onset can occur at any age, the annual incidence of new cases is highest for children and adolescents (70 per 100,000).^6,2  Paediatric epilepsy can be particularly challenging for children due to neurocognitive, behavioural, social, and psychiatric difficulties occurring during an important period of learning and development.⁷ This not only impacts on patients quality of life but can also add to the emotional burden felt by parents and caregivers.⁸

For Eisai, neurology, including epilepsy, is a therapeutic area of focus and in continued pursuit of our mission to provide “seizure freedom” to a greater number of patients living with epilepsy Eisai seeks to address the diverse needs of, as well as increasing the benefits provided to, patients with epilepsy and their families.