HATFIELD, England, June 25, 2013 /PRNewswire/ --
The company continues to disagree with the German Federal Joint Committee's (G-BA)decision on drug's additional benefits but will continue patient access
Eisai today announces, with regret, that it will suspend temporarily commercial distribution (Aussetzen des Vertriebes) of Fycompa in Germany. Eisai is unable to accept the assessment, under the current AMNOG (Arzneimittelmarkt-Neuordnungsgesetz) process, of no additional benefit to inappropriate comparators for this highly innovative, first in class product. Eisai hopes that this situation will be temporary and will submit Fycompa for reassessment at the earliest opportunity. Commercial availability of Fycompa will continue until the end of the year. Thereafter, a continued access programme will be put in place. Eisai will announce the details of the continued access programme shortly.
The German Society for Epileptology (DGfE) and German Society for Neurology (DGN), representing epileptologists and neurologists in Germany, agree that the G-BA's understanding that new anti-epileptic drugs should be compared to single substances is not applicable to the situation of refractory epilepsy, for which an additional benefit should be assessed by considering efficacy in patients drug-resistant to standard therapies. The organisations also confirm that new epilepsy treatment options are needed to help patients improve seizure control and tolerability.
"We deeply regret having to take the difficult decision to suspend temporarily our innovative new anti-epileptic drug Fycompa from commercial distribution in Germany. We continue 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." said Gary Hendler, President and CEO, Eisai EMEA. "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. We intend to submit Fycompa for reassessment at the earliest opportunity. Since the drug's launch in September 2012, its clinical benefit has been recognised in approximately 3000-4000 patients suffering with epilepsy in Germany and our first concern is therefore for these patients. As a demonstration of our strong belief in Fycompa and our commitment to people suffering with epilepsy in Germany, Eisai will ensure that all patients will continue to receive access to this first-in-class treatment."
Discovered and developed by Eisai in the UK and Japan, Fycompa is the first and only approved anti-epileptic drug in Europe with a mode of action that selectively targets AMPA receptors, thought to play a central role in seizure generation and spread.[1] The successful treatment of partial-onset seizures remains a challenge for patients and physicians as over 30% of patients do not achieve seizure freedom, despite appropriate therapy with anti-epileptic drugs, making new innovative therapeutic options very important.[2]
Fycompa was granted marketing authorization by the European Commission on 23 July 2012 and is indicated for the adjunctive treatment of partial-onset seizures with or without secondarily generalised seizures in patients with epilepsy aged 12 years and older. In Germany, approximately one out of 200 people has epilepsy equating to an estimated 400,000 people in the country living with the condition.[3]
Eisai is a leading research and development based pharmaceutical company. The company's Corporate Philosophy is to give first thought to patients and their families, and to increase the benefits that health care provides to them. Eisai calls this philosophy human healthcare (hhc). Eisai's believes that the hhc philosophy is its primary objective and that only through focussing on the needs of the patient and the wider global healthcare system that sales and earnings will be generated. Guided by our hhc philosophy, Eisai will continue to work to achieve sustainable enhancement of value through its business activities worldwide.
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Eisai Announces That it Will Suspend Temporarily Commercial Distribution of Innovative Antiepileptic Drug Fycompa® ...