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11
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English
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Documents
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2014
Description
Fycompa® (Perampanel) to beFycompa® (Perampanel) to be Resubmitted Early to German Federal Joint Committee (G-BA) for Additional Benefit Assessment PR Newswire HATFIELD, England, February 10, 2014 PRESS RELEASE NOT FOR U.S. MEDIA Early resubmission opportunity for epilepsy drug perampanel welcomed by Eisai The German Federal Joint Committee (G-BA), the decision-making body of the self-governing healthcare system in Germany, recently confirmed that ®Eisai will be able to resubmit early its anti-epileptic drug (AED) Fycompa (perampanel) for reassessment of its additional therapeutic benefits. Perampanel is indicated for the adjunctive treatment of partial onset seizures, with or without secondarily generalised seizures, in people with [1]epilepsy aged 12 years and older. The confirmation from the G-BA gives Eisai the right to resubmit perampanel for additional benefit reassessment within three months now. Once resubmitted, the new G-BA decision is expected to be published within 6 months. "It is right that the G-BA has permitted the early resubmission of Fycompa in Germany," said Gary Hendler, President & CEO, Eisai EMEA. "Patients are Eisai's first concern and we strongly believe they should be given access to treatment that provides a clear clinical benefit.
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Publié par
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Publié le
09 février 2014
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Langue
English