Posted by Michael Wonder on 23 Sep 2020
Eisai receives positive opinion from EMA's CHMP on use of anti-epileptic agent Fycompa in paediatric patients
23 September 2020 - Eisai announced that it has received a positive opinion from the EMA’s CHMP on the license extension application submitted by its U.K. subsidiary Eisai regarding the use of its in-house discovered and developed anti-epileptic agent Fycompa (perampanel) in the treatment of paediatric patients.
The CHMP's positive opinion is to extend the use of Fycompa as an adjunctive therapy for partial-onset seizures (POS) (with or without secondary generalisation) by expanding the approved age range from 12 years and above to 4 years and above, and for primary generalised tonic-clonic seizures (PGTCS) from 12 years and above to 7 years and above.
The application, submitted to EMA in February 2019, was based on the results of Phase 3 (Study 311) and Phase 2 (Study 232) clinical studies conducted globally to evaluate Fycompa as an adjunctive therapy in paediatric patients with POS or PGTCS.
