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Zonegran® (zonisamide) Reimbursed in Switzerland as Monotherapy Treatment for Adults With Newly Diagnosed Partial Epilepsy

HATFIELD, England, January 23, 2014 /PRNewswire/ --


PRESS RELEASE FOR EUROPEAN MEDIA ONLY NOT FOR U.S. MEDIA

Zonegran also receives Swissmedic approval as adjunctive therapy for children and adolescents

Zonegran® (zonisamide) has received reimbursement in Switzerland by the Federal Office of Public Health (FOPH) as monotherapy in the treatment of partial seizures, with or without secondary generalisation, in adults with newly diagnosed epilepsy. The reimbursement for zonisamide follows Swissmedic approval earlier this year. Zonisamide is also now available for the treatment of partial epilepsy in children and adolescents in Switzerland following the paediatric license extension approval by the European Commission in October 2013.

Already available in Switzerland as adjunctive therapy for the treatment of partial seizures with or without secondary generalisation in patients over the age of 18, once-daily zonisamide is a second generation anti-epileptic drug (AED) with multiple mechanisms of action and a chemical structure unrelated to any other AEDs.[1] Monotherapy is the favoured approach in managing newly diagnosed epilepsy as most people with epilepsy may be successfully managed with the first or second monotherapy. In comparison with polytherapy, monotherapy also reduces the potential for adverse drug interactions.[2]

"Effective seizure management still remains a challenge for up to a third of people with partial onset seizure despite appropriate therapy. The reimbursement of Zonegran as monotherapy in adults and the approval as adjunctive therapy in children and adolescents offers another treatment option that can potentially help people in Switzerland achieve better seizure control," commented Dr. Günter Krämer,Neurologist, Neurozentrum Bellevue, Zurich.

Epilepsy is one of the most common neurological conditions in the world[3] and an estimated 70,000 people live with epilepsy in Switzerland.[4] The incidence of uncontrolled partial epilepsy remains high despite many new AEDs, and between 20-40% of people with newly diagnosed epilepsy will become refractory to treatment.[5]

The efficacy and safety of zonisamide as monotherapy was demonstrated in a double-blind, randomised, multicentre study of 583 newly diagnosed adult partial epilepsy patients, which compared the efficacy and safety of once-daily zonisamide with twice-daily controlled release carbamazepine as monotherapy. The study's primary endpoint was the proportion of seizure-free patients at six months. Zonisamide demonstrated high response rates for achieving seizure freedom in newly diagnosed patients with epilepsy,[6] similar to controlled release carbamazepine. In the majority of patients, seizure freedom was achieved at the target dose of 300 mg with once daily dosing. Zonisamide was considered non-inferior to carbamazepine, was well tolerated, and had no apparent safety concerns after one year of treatment at doses ranging from 300 to 500 mg/day.

"We are pleased to receive the new extended monotherapy and adjunctive therapy indication for Zonegran in Switzerland which reinforces Eisai's human health care mission (hhc) to provide effective treatments to patients worldwide," said Christiane Kordeuter, Epilepsy Business Unit Director, Eisai Switzerland.

The continued development of zonisamide 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. Eisai is committed to the therapeutic area of epilepsy and addressing the unmet medical needs of people with epilepsy and their families. Eisai is proud to market currently more epilepsy products in EMEA than any other company.

Notes to Editors

About Zonegran (zonisamide)

Zonisamide is licensed in Europe as monotherapy in the treatment of partial seizures, with or without secondary generalisation, in adults with newly diagnosed epilepsy. Zonisamide is also indicated as adjunctive therapy in the treatment of partial seizures, with or without secondary generalisation, in adults, adolescents and children aged six years and above.[1] It has a broad spectrum of anti-epileptic modes of action and has no appreciable effects on steady-state plasma concentrations of other AEDs, such as phenytoin, carbamazepine and valproate.[1] Zonegran is one of only four AEDs with level A efficacy/effectiveness evidence as initial monotherapy for adults with partial onset seizures.[7]

Zonisamide is available in 25mg, 50mg, and 100mg capsule strengths. The recommended daily dose for monotherapy use is 100mg once daily. In the third and fourth weeks the dose may be increased to 200mg daily and then increased to 300mg daily after the next two weeks.The recommended initial daily dose for adjunctive use is 50mg in two divided doses. After one week the dose may be increased to 100 mg daily and thereafter the dose may be increased at weekly intervals, in increments of up to 100mg.[1]

For more information please visit: http://www.zonegran.eu

About Epilepsy

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 worldwide.[8],[9] Epilepsy is a chronic disorder of the brain that affects people of all ages. It is characterised by abnormal discharges of neuronal activity which causes 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 EMEA 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, Russia and Oceania (EMEA).

In the EMEA region, Eisai currently has four marketed treatments including:

  • Zonegran® (zonisamide) as monotherapy in adults and adjunctive therapy in adults, adolescents and children aged six years and above 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. (Rufinamide was originally developed by Novartis)
  • 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

About Eisai

Eisai is one of the world's leading research and development (R&D) based pharmaceutical companies and we define our corporate mission as "giving first thought to patients and their families and to increasing the benefits health care provides," which we call human health care (hhc).

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 10,000 people worldwide. From its EMEA Knowledge Centre in Hatfield, UK, Eisai has recently expanded its business operations to include Europe, the Middle East, Africa, Russia and Oceania (EMEA). Eisai EMEA has sales and marketing operations in over 20 markets, including the United Kingdom, France, Germany, Italy, Spain, Switzerland, Sweden, Ireland, Austria, Denmark, Finland, Norway, Portugal, Czech Republic, Slovakia, the Netherlands, Belgium, Russia and the Middle East.

For further information please visit our web site http://www.eisai.co.uk

References

  1. Eisai Ltd 2013. Zonegran summary of product characteristics (last updated October 2013)https://www.medicines.org.uk/emc/history/16240/SPC/Zonegran+25,+50,+100+mg+Hard+Capsules
  2. St. Louis, K. Rosenfeld. W. Bramley, T. Antiepileptic Drug Monotherapy: The Initial Approach in Epilepsy Management (2009) &(2): 77-72
  3. 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 Feb 2013)
  4. EPI Swiss Epilepsy Centre. Available at: http://www.epi.ch/page.php?pages_id=301&language=fr (Accessed November 2013)
  5. French JA. Refractory Epilepsy; Clinical Overview. Epilepsia 2007: 48 (Suppl1) 3 - 7.
  6. Baulac M. et al. M. Efficacy and tolerability of zonisamide versus controlled-release carbamazepine for newly diagnosed partial epilepsy: a phase 3, randomised, double-blind, non-inferiority trial. Lancet Neurology (2012), 11 (7) 579 - 588
  7. Glauser T. et al. Updated ILAE evidence review of antiepileptic drug efficacy and effectiveness as initial monotherapy for epileptic seizures and syndromes.
  8. Epilepsy in the WHO European Region: Fostering Epilepsy Care in Europe. http://www.ibe-epilepsy.org/downloads/EURO%20Report%20160510.pdf (Accessed December 2013)
  9. Pugliatti M, et al. Estimating the cost of epilepsy in Europe: A review with economic modeling. Epilepsia 2007; 48(12) 2224-2233.

Date of preparation: November 2013
Job code: Zonegran-UK2515


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