The Federal Joint Committee (G-BA), the supreme decision-making body of the joint self-administration in the German health care system has confirmed that Eisai's epilepsy drug Fycompa (perampanel) may be submitted for re-benefit assessment at an early stage. Perampanel is indicated as adjunctive treatment of partial seizures with or without secondary generalization in patients with epilepsy aged 12 years.

The G-BA decision makes it Eisai now possible to submit perampanel for re-evaluation of the added value within three months. After the submission can be expected with a publication of the decision by the G-BA within six months.

"It is right that Eisai may submit for re-benefit assessment in Germany Fycompa at the G-BA," says Gary Hendler, president & CEO, Eisai EMEA. "Our first concern is for the patient and we are convinced that they should have access to treatment options that bring a clear clinical benefit. Since the launch of Fycompa in Europe in September 2012, the clinical benefit of the treatment of about 4,000 patients with epilepsy was in Germany shown. Therefore, we hope that the drug in the near future even more patients will be available."

After the negative assessment by the G-BA sat Eisai sales of perampanel July 1, 2013 temporarily and set up, run by the Clinigen Group programme for individual importation (Named Patient Access Programme) in order to ensure that people with epilepsy continue to be supplied completely with the antiepileptic drug at no cost to the German health care system, while the G-BA a early re-application position checks.

"The decision of the G-BA is good news for patients and physicians in Germany," Professor Bernhard Steinhoff from the Epilepsy Centre Kork, Kehl-Kork. "Hundreds of thousands of people in Germany suffer from epilepsy, and treatment options such Fycompa are a welcome addition to our existing treatment options."

"We are pleased that the G-BA has agreed to an early re-filing of the application for perampanel and will continue to pursue the assessment process for all antiepileptic drugs exactly," commented Professor Heinz Beck, chairman of the German Society of Epileptology (DGfE). "The best possible treatment for our patients with epilepsy contribution of our clinical expertise is an important part of our daily work and significant developments like this are always interesting."

In Germany, about one in 200 people suffers from epilepsy. This means that an estimated 400,000 people live with this disease. Epilepsy is one of the most common neurological disorders worldwide. The successful treatment of partial seizures continues to be a challenge, since up to 30 per cent of patients despite appropriate therapy with antiepileptic drugs do not achieve seizure freedom.

Perampanel was developed by Eisai in the UK and Japan developed and is the first and only approved anti-epileptic drug in Europe, which attacks selectively on AMPA receptors, which are supposed to play a crucial role in the initiation and spread of seizures.

Eisai is a leader in pharmaceutical research. The company's philosophy provides patients and their families in first place and is aimed at improving health care for these patients. Eisai calls this philosophy "human health care" (hhc).

Eisai is committed to developing and delivering highly beneficial new treatments to improve the lives of people with epilepsy. The development of anticonvulsant drugs is a major strategic area for Eisai in Europe, Middle East, Africa, Russia and Oceania (EMEA).

Eisai is one of the world's leading research and development-oriented (R&D) pharmaceutical companies and has defined its corporate mission as follows: first thought to patients and their families and to improve the health care available - we call human health care (hhc).


Clinigen Group is a global pharmaceutical company and has three operating companies; Specialty Pharmaceuticals (Clinigen SP), Clinical Trials Supply (Clinigen CTS) and Global Access Programme (GAP Clinigen).