HATFIELD, England, November 6, 2014 /PRNewswire/ -- Eisai announces with utmost disappointment that the German Federal Joint Committee (G-BA) has decided that the additional benefit for new generation anti-epileptic drug (AED) Fycompa (perampanel) has not been proven, when compared to conventional AEDs as defined by the G-BA.[1] The decision, based on methodological rather than clinical considerations, ignores the demands of the German Epilepsy Association (DE) and other epilepsy patient advocacy groups to recognise the additional benefit seen in practical applications as well as in studies.[2] The decision also ignores the recommendations of the German Society of Epileptology (DGfE) to assess the additional benefit of new AEDs. The efficacy and tolerability of adjunctive perampanel in the treatment of partial onset seizures in real world clinical practice has been demonstrated by a multi-centre, six-month observational study from nine epilepsy centres in Germany and Austria. The results show that half of the 281 people with highly refractory epilepsy treated with perampanel experienced at least a 50% reduction in seizure frequency and up to 15% became seizure free during the observation period.[3] "We are utterly disappointed by the decision of the German Joint Federal Committee (G-BA) not to recognise the additional benefit of perampanel … Continue reading
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