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news.Eisai has announced the temporary suspension of the commercial distribution of antiepileptic drug, AMPA receptor antagonist Fycompa (Perampanel), in Germany.
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With the continuation of commercial availability until the end of 2013, the temporary suspension was based on the German Federal Joint Committee’s (G-BA) decision on drug’s additional benefits with which the company disagrees.
Expected to submit for reassessment at the earliest, the company plans to continue to ensure access to the drug for patients in need of fycompa treatment even after suspension through a continued access programme.
Eisai EMEA president and CEO Gary Hendler said the company continues to disagree with the decision made by the GB-A in its current assessment of Fycompa.
"We are hopeful that this will be rectified in the potential changes in the German Law on Medicine," Hendler added.
"We are watching closely for any further developments, we are positive we will be able to resolve the situation and re-start commercial distribution of Fycompa in Germany."
The comparison of the new anti-epileptic drugs to single substances is not applicable to the situation of refractory epilepsy where an additional benefit should be assessed by considering efficacy in patients drug-resistant to standard therapies, according to the German Society for Epileptology and German Society for Neurology.