Eisai Suspends Epilepsy Drug, Fycompa, in Germany

Eisai is to suspend commercial distribution of its new epilepsy drug Fycompa in Germany, noting that they continue to disagree with the country’s reimbursement regulatory body’s rejection of the therapy.

In March, the German Federal Joint Committee declared that they consider the additional benefit of Fycompa unproven when compared to two other treatments – GlaxoSmithKline’s Lamicta, which was the principal comparator, and Johnson & Johnson’s Topamax.

Eisai stress that they will carry on with their patient access programmes but says they are unable to accept the decision, which was made using the controversial AMNOG pricing structure.  The company claims that the GlaxoSmithKline and Johnson & Johnson drugs are “inappropriate comparators for this highly innovative, first-in-class product.”  The company has confirmed that the commercial availability of Fycompa will discontinue at the end of 2013.

Eisai commented that they hope the situation will only be temporary, and confirmed that they will be submitting Fycompa for reassessment “at the earliest opportunity.”  Gary Hendler, head of Eisai’s operations in Europe, the Middle East and Africa (EMEA), commented that the company “are watching closely for any further developments [and] we are positive we will be able to resolve the situation,” adding that “we are hopeful that this will be rectified in the potential changes in the German Law on Medicine.”

Since the drug’s launch in September 2012, Mr Hendler noted that Fycompa’s clinical benefit has been recognised in 3,000-4,000 patients suffering with epilepsy in Germany.  The company has received the backing of the German Society for Epileptology and German Society for Neurology.

Fycompa is the only approved anti-epileptic in Europe which selectively targets AMPA receptors, thought to play a central role in seizure generation and spread.  Eisai noted that more than 30% of patients do not achieve seizure freedom, despite appropriate therapy, “making new innovative therapeutic options very important.”

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