3 days popular7 days popular1 month popular3 months popular

First-in-class epilepsy treatment Fycompa® (perampanel) launches in Australia

Fycompa® (perampanel), the first in an entirely new class of treatment for (the most common form of epilepsy), has received reimbursement in . It 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.[i]

Perampanel is the only licensed anti-epileptic drug (AED) to selectively target AMPA receptors, a protein in the brain which plays a critical role in the spread of seizures.[ii] This mechanism of action is different to other currently available AEDs. In addition, perampanel has the added benefit of convenient, once-daily dosing at bedtime1 and, significantly, is the only new-generation partial approved to treat adolescents (>12 years) with epilepsy from launch.

Epilepsy is one of the most common neurological conditions in the world.[iii] In Australia it is estimated that 225,000 Australians live with epilepsy, and approximately 800,000 will be diagnosed with the condition at some stage in their life.[iv] The successful treatment of partial onset seizures remains a significant challenge in some people and the incidence of uncontrolled partial epilepsy remains high despite many AEDs. Currently, between 20-40% of people with newly diagnosed epilepsy will become refractory to treatment.[v]

“There is an ongoing need for effective and well-tolerated treatment options for people with pharmacoresistant epilepsy, particularly as many will try a range of drugs before finding one that works for them. Fycompa is a mechanistically unique new agent, whose launch in Australia will be welcomed by patients and their doctors,” Professor Martin Brodie, Clinical and Research Director of the Epilepsy Unit at the University of Glasgow in Scotland..

Three global pivotal studies show consistent results in the efficacy and tolerability of perampanel as an adjunctive therapy in people with partial onset seizures, with or without secondary generalisation. The most commonly reported adverse events were dizziness, somnolence, fatigue, headache, falls, irritability and ataxia.[vi][vii][viii] Results from the open-label extension study demonstrate perampanel’s efficacy and favourable tolerability profile longer term.[ix]

Discovered and developed by Eisai in Europe and Japan, perampanel is manufactured in the UK and was approved by the European Commission on 23 July 2012.

The launch of perampanel in Australia 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.

Source

[i] Australia Government, Department of Health. Pharmaceutical Benefits Scheme. Available at http://www.pbs.gov.au/pbs/home Accessed: October 2014

[ii] Rogawski MA. Revisiting AMPA receptors as an antiepileptic drug target. Epilepsy Currents 2011;11:56–63

[iii] ILAE/IBE/WHO, Epilepsy in the WHO European Region: Fostering Epilepsy Care in Europe 2010. Available at; http://www.ilae.org/Visitors/Documents/ILAEAnnual-Report2010Final_000.pdf Accessed: October 2014

[iv] Epilepsy Action Australia. Facts and statistics about Epilepsy. Available at: http://www.epilepsy.org.au/resources/for-media/facts-statistics-about-epilepsy Accessed: October 2014

[v] French JA. Refractory Epilepsy; Clinical Overview. Epilepsia 2007: 48 (Suppl1) 3-7

[vi] French JA et al. Adjunctive perampanel for refractory partial-onset seizures: randomized phase III study 304. Neurology 2012:79(6):589-596

[vii] French JA et al. Evaluation of adjunctive perampanel in patients with refractory partial-onset seizures: Results of randomized global phase III study 305. Epilepsia 2013:54(1):117-125

[viii] Krauss GM et al. Randomized phase III study 306: Adjunctive perampanel for refractory partial-onset seizures. Neurology 2012:78(18):1408-1415

[ix] Krauss GL et al. Long-term safety of perampanel and seizure outcomes in refractory partial-onset seizures and secondarily generalised seizures: Results from Phase III extension study 307. Epilepsia 2014;55:1058-1068

Source: Eisai Co., Ltd