HATFIELD, England, December 10, 2012 /PRNewswire/ --
Fycompa (perampanel), a treatment for partial epilepsy, is now approved for use in Scotland after a decision by The Scottish Medicines Consortium (SMC). It is approved for use as a second-line adjunctive treatment in patients with refractory partial-onset epilepsy.
Almost 54,000 people in Scotland have epilepsy, one of the most common neurological diseases. The number of people affected by the condition has been on the increase in Scotland, which saw nearly a 40% increase in six years signifying a critical need for effective treatments for managing the condition. The SMC approval for perampanel is the first health technology appraisal (HTA) globally.
"This approval from the SMC is a positive step in the management of people with epilepsy in Scotland. Uncontrolled seizures have a severe impact on everyday function and quality of life and so we look forward to the possibility of being able to offer our epilepsy patients a new treatment option," comments Professor Martin Brodie, Professor of Medicine and Clinical Pharmacology at the University of Glasgow and Director of the Epilepsy Unit at the city's Western Infirmary.
The data supports the use of perampanel as a new therapeutic option for this hard-to-treat patient population. The successful treatment of partial-onset seizures (the most common form of epilepsy) remains a significant challenge in some patients and the incidence of uncontrolled partial epilepsy remains high, despite many existing anti-epileptic drugs (AEDs); between 20 - 40% of patients with epilepsy have remained poorly controlled despite these treatments. Fycompa is licensed as an adjunctive treatment for partial-onset seizures with or without secondarily generalised seizures in patients with epilepsy aged 12 years and older.
Nick Burgin, Director Market Access, Eisai EMEA & Russia explained: "We are delighted that SMC has approved perampanel for partial epilepsy - this is the first health technology approval (HTA) in Europe and demonstrates the SMC's commitment to giving patients access to innovative medicines - encouraging better patient outcomes. We hope to see other HTA bodies following their lead and approving perampanel across Europe."
Discovered and developed by Eisai in the UK and Japan, perampanel is the first and only licensed AED in Europe with a mode of action that selectively targets AMPA receptors, which are thought to play a central role in seizure generation and spread. This first in class treatment selectively targets the transmission of seizures by blocking the effects of glutamate, which can trigger and maintain seizures. In addition, perampanel has the added benefit of convenient, once-daily dosing taken at bedtime, and it is the only third generation epilepsy treatment approved for adolescents which can lead to earlier seizure control in younger patients.
The European Commission's (EC) Marketing Authorisation Approval of perampanel was based on three global pivotal Phase III studies with 1,480 subjects. These randomised, double-blind, placebo-controlled, and dose-escalated studies showed consistent results in the efficacyand tolerability of perampanel as an adjunctive therapy in patients with partial-onset seizures (with or without secondary generalisations).,, The most commonly reported adverse events were dizziness, headaches, somnolence, irritability, fatigue, falls, and ataxia.,,
The development of perampanel underscores Eisai's human health care mission, the company's commitment to innovative solutions in disease prevention, cure and care for the health and well being of people worldwide. Eisai is committed to the therapeutic area of epilepsy and addressing the unmet medical needs of patients and their families.
Notes to Editors
Perampanel is licensed in Europe Union as an adjunctive treatment for people aged 12 years and older with partial-onset seizures, with or without secondarily generalised seizures.
Perampanel is a highly selective, non-competitive AMPA (alpha-amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid)-type glutamate receptor antagonist that has demonstrated seizure reduction in Phase II and III studies. AMPA receptors, widely present in almost all excitatory neurons, transmit signals stimulated by the excitatory neurotransmitter glutamate within the brain and are believed to play a role in central nervous system diseases characterised by excess neuroexcitatory signaling including epilepsy .
Further information for healthcare professionals can be found at http://www.fycompa.eu
About the Perampanel pooled data (Study 306, 305 and 304)
The pooled Phase III data analysed the efficacy of once-daily perampanel in reducing partial-onset seizures, the most common form of epilepsy, and its effectiveness and flexibility of use as add-on therapy. Perampanel is licensed for the adjunctive treatment of partial-onset seizures with or without secondarily generalized seizures in patients with epilepsy. The Scottish Medicines Consortium (SMC) considers perampanel when positioned for use as a second-line adjunctive treatment in patients with refractory partial onset epilepsy i.e. patients who have previously received monotherapy and are not seizure free after at least one other adjunctive therapy.
Results from two separate analyses of pooled data from the perampanel pivotal Phase III clinical trial programme endorse the efficacy and safety of the new AED at clinically relevant doses. In addition, the results show that perampanel decreased the frequency of both complex partial seizures and secondarily generalised seizures. In a third analysis of the pooled trial data, patients with uncontrolled partial-onset seizures taking any of the five most commonly-used AEDs with perampanel as an add-on therapy experienced a reduction in their seizure frequency. Patients generally received additional benefit from increased doses of perampanel.
The clinical development plan for perampanel consisted of three global Phase III studies (studies 306, 305 and 304). The key goal of Study 306 was to identify the minimal effective dose and included four treatment arms (placebo, 2mg, 4mg, and 8mg). Study 304 and Study 305 included three arms (placebo, 8mg, and 12mg) and were to evaluate a more extended dose range. The studies were similar in design: global, randomised, double-blind, placebo-controlled, dose-escalation, parallel-group studies. The primary and secondary endpoints were the same in all the studies: percentage change in seizure frequency, 50% responder rate, percentage reduction of complex partial plus secondarily generalised seizures, and evaluation for dose response. The primary endpoint for the EMA is 50% responder rate and for the FDA is median percent change in seizure frequency.
Epilepsy is one of the most common neurological conditions in the world, affecting approximately eight in 1,000 people in Europe, and an estimated 50 million people with the condition worldwide., Epilepsy is a chronic disorder of the brain that affects people of all ages. It is characterised by abnormal discharges of neuronal activity causing seizures. Seizures can vary in severity, from brief lapses of attention or jerking of muscles, to severe and prolonged convulsions. Depending on the seizure type, seizures may be limited to one part of the body, or may involve the whole body. Seizures can also vary in frequency from less than one per year, to several per day. Epilepsy has many possible causes but often the cause is unknown.
About Eisai Europe in Epilepsy
Eisai is committed to developing and delivering highly beneficial new treatments to help improve the lives of people with epilepsy. The development of AEDs is a major strategic area for Eisai in Europe, the Middle East, Africa and Russia (EMEA).
In the EMEA region, Eisai currently has four marketed treatments including:
- Zonegran® (zonisamide) as monotherapy and adjunctive therapy in adult patients with partial-onset seizures, with or without secondary generalisation. (Zonegran is under license from the originator Dainippon Sumitomo Pharma)
- Zebinix® (eslicarbazepine acetate) as adjunctive therapy in adult patients with partial-onset seizures, with or without secondary generalisation. (Zebinix is under license from BIAL)
- Inovelon® (rufinamide) for the adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome in patients >4 years
- Fycompa® (perampanel) for use as an adjunctive treatment for partial onset seizures, with or without secondarily generalised seizures, in patients with epilepsy aged 12 years and older
Eisai recently expanded their UK Hatfield commercial, research and manufacturing facility which now supports the company's growing EMEA business.
Eisai concentrates its R&D activities in three key areas:
- Neuroscience, including: Alzheimer's disease, epilepsy, pain and weight loss
- Oncology including: anticancer therapies; tumour regression, tumour suppression, antibodies, etc.
- Vascular/Immunological reaction including: thrombocytopenia, rheumatoid arthritis, psoriasis, inflammatory bowel disease
With operations in the U.S., Asia, Europe and its domestic home market of Japan, Eisai employs more than 11,000 people worldwide. In Europe, Eisai undertakes sales and marketing operations in over 20 markets, including the United Kingdom, France, Germany, Italy, Spain, Switzerland, Sweden, Ireland, Austria, Denmark, Finland, Norway, Portugal, Iceland, Czech Republic, Slovakia, the Netherlands, Belgium, Luxembourg, the Middle East and Russia. For further information please visit our web site http://www.eisai.com.
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Date of preparation: December 2012
Job Code: Perampanel-UK2116