EU approves Fycompa (Eisai) for treatment of Epilepsy - 29-Jul-2012
The European Commission has granted marketing authorisation approval for the use of Fycompa (perampanel) from Eisai as an adjunctive treatment of partial-onset seizures, with or without secondarily generalised seizures, in people with Epilepsy aged 12 years and older.The FDA issued a refusal to file letter for perampanel in July 2011, following a preliminary review of the acceptability of the original data package submitted the previous May. A resubmission from Eisai was accepted for review by the FDA in March this year.
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Succesful Phase III studies with Fycompa (Eisai) for Epilepsy published in Epilepsia
Two analyses show Fycompa (Eisai) effective for Epilepsy
Early prediction of Epileptic seizures study from NeuroVista
German Federal Joint Committee decides additional benefit of Fycompa (Eisai) unproven as a treatment for Epilepsy
Phase III success for Vimpat (UCB) as monotherapy for treatment of partial onset seizures
Lyrica (Pfizer) as effective as Keppra (UCB) for Epilepsy treatment
Phase II study of Monarch eTNS (NeuroSigma) shows benefits for Epilepsy
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