Eisai is to suspend commercial distribution of its new epilepsy drug Fycompa in Germany, saying it continues to disagree with the country's reimbursement regulatory body's rejection of the therapy.
In March, the German Federal Joint Committee (G-BA) announced that it considers the additional benefit of Fycompa (perampanel) unproven when compared to two other treatments - GlaxoSmithKline's Lamicta (lamotrigine), which was the principal comparator, and Johnson & Johnson's Topamax (topiramate).
The Japan-headquartered drugmaker stresses that it will continue with patient access programmes bu tsays it is unable to accept the assessment, carried out using the controversial AMNOG pricing structure. It states that the GSK and J&J drugs are"inappropriate comparators for this highly innovative, first-in-class product" and so commercial availability of Fycompa will stop at the end of the year.
Eisai said it hopes that this situation will be temporary and will submit Fycompa for reassessment "at the earliest opportunity". Gary Hendler, head of the company's operations in Europe, the Middle East and Africa (EMEA), said that "we are watching closely for any further developments [and] we are positive we will be able to resolve the situation, noting 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 said its clinical benefit has been recognised in 3,000-4,000 patients suffering with epilepsy in Germany and "Eisai will ensure that all patients will continue to receive access to this first-in-class treatment". The company has the backing of the German Society for Epileptology (DGfE) and German Society for Neurology (DGN).
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 over 30% of patients do not achieve seizure freedom, despite appropriate therapy, "making new innovative therapeutic options very important".