HATFIELD, England, December 2, 2013 /PRNewswire/ --
Epilepsy treatment Fycompa(R)(perampanel) has today been approved for basic reimbursement in Finland. Perampanel is indicated as an adjunctive treatment for partial onset seizures, with or without secondarily generalised seizures, in people with epilepsy aged 12 years and older.[1]
Perampanel is the first and only licensed anti-epileptic drug (AED) to selectively target AMPA receptors, a protein in the brain which plays a critical role in causing seizures.[2] This mechanism of action is different to other, currently available AEDs. In addition, perampanel has the added benefit of convenient, once-daily dosing at bedtime[1] and, significantly, is the only new-generation partial epilepsy treatment approved to treat adolescents with epilepsy from launch.
"Perampanel is an important new treatment option for people with partial onset epilepsy in Finland, and particularly those who live with uncontrolled seizures," said Dr. Jukka Peltola, Department of Neurology, Tampere University hospital. "Epilepsy remains a challenging condition to treat, so perampanel will be welcomed by doctors across the country as an alternative option which may help people with epilepsy to achieve better seizure control."
Epilepsy is one of the most common neurological conditions in the world and in Finland alone approximately 56,000 people live with the condition.[3] Despite many AEDs, the successful treatment of partial onset seizures remains a significant challenge in some patients. Currently, between 20-40% of patients with newly diagnosed epilepsy will become refractory to treatment.[4]
Perampanel was approved by the European Commission on 23 July 2012 based on three randomised, double-blind, placebo-controlled and dose-escalated global pivotal Phase III studies (304, 305, 306) and an open-label extension study (307). The three global pivotal studies show consistent results in the efficacyand tolerability of perampanel as an adjunctive therapy in people with partial onset seizures, with or without secondary generalisation.[5],[6],[7] The most commonly reported adverse events were dizziness, somnolence, fatigue, headache, falls, irritability and ataxia.[5],[6],[7] Results from the open-label extension study also demonstrate perampanel's efficacy and favorable tolerability profile over the longer term.[8]
Sten Friberg, Nordic Medical Director for Eisai AB commented, "We are delighted to announce the launch of Fycompa in Finland. As an emerging leader in the field of epilepsy, Eisai is committed to the development of innovative therapies such as this to help people with epilepsy achieve seizure control."
The launch of perampanel in Finland underscores Eisai's human health care (hhc) mission, the company's commitment to innovative solutions in disease prevention, cure and care for the health and wellbeing of people worldwide.
Notes to Editors
About Perampanel
Perampanel is licensed in the European Union (EU) as an adjunctive treatment for people aged 12 years and older with partial onset seizures, with or without secondarily generalised seizures. [1]
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 signalling including epilepsy. [1]
For more information please visit: http://www.fycompa.eu
About the Perampanel Pooled Data (Study 306, 305 and 304)[5],[6],[7]
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. Efficacy end points for studies 304, 305, and 306 were pooled according to randomised treatment: placebo, perampanel 2, 4, 8 or 12mg. The full ITT (intention-to-treat) analysis set included 1,478 patients from studies 304 (n=387), 2 Dic. (n=386) - and 306 (n=705).
Median reductions in partial seizure frequency were greater with perampanel 4 mg (-23.3%), 8 mg (-28.8%), and 12 mg (-27.2%) than placebo (-12.8%; p<0.01, each dose vs placebo). Median (95% CI) differences from placebo in changes in partial seizure frequency were -12.2% (-20.1 to -4.6), -17.9% (-24.1 to -11.8), and -15.8% (-23.0 to -8.7) for perampanel 4, 8, and 12 mg, respectively.[9]
50% responder rates were greater with perampanel 4 mg (28.5%), 8 mg (35.3%), and 12 mg (35.0%) than placebo (19.3%; p<0.05, each dose vs placebo). Median reductions in complex partial seizure frequency were greater with perampanel 4 mg (-31.2%), 8 mg (-35.6%), and 12 mg (-28.6%) than placebo (-13.9%).[1]
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.[9] In addition, the results show that perampanel decreased the frequency of both complex partial seizures and secondarily generalised seizures.[10] 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.[11]
Perampanel was generally well tolerated; most adverse events were mild/moderate.
About 307[8]
The 307 study (n=1,218) was designed to evaluate safety, tolerability, and seizure outcome data during long-term treatment with once-daily adjunctive perampanel (up to 12 mg/day) in people with refractory partial onset seizures. It was an open-label extension (OLE) study for people completing the double-blind phase of three pivotal Phase III trials (studies 304, 305, and 306).
The study consisted of two phases: an open-label treatment phase (including a 16-week conversion period and a planned 256-week maintenance period) and a 4-week follow-up phase. People were blindly titrated during the Conversion Period to their individual maximum tolerated dose (maximum 12 mg/day). Adverse events (AEs) were monitored throughout the study and seizure frequency recorded. The interim data cut-off date for analyses was 1 December 1 2010.
At the interim cut-off date, 1186 patients were in the safety analysis set; 1089 (91.8%) patients had >16 weeks' exposure to perampanel, 580 (48.9%) patients had >1 year of exposure, and 19 (1.6%) patients had >2 years' exposure. At the interim analysis, 840 (70.8%) patients remained on perampanel treatment. The large majority of patients (n=1084 [91%]) were titrated to 10 mg or 12 mg/day. Median (range) duration of exposure was 51.4 (1.1-128.1) weeks.
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