Italian Medicines Agency (AIFA) Approves the Reimbursement of Zonegran® (zonisamide) Monotherapy Treatment for Adults with Newly Diagnosed Partial Epilepsy

HATFIELD, England, October 22, 2013 /PRNewswire/ --

Class A reimbursement granted for Zonegran^®(zonisamide) for patients with newly diagnosed epilepsy

Zonegran^® (zonisamide) has now received class A reimbursement in Italy as monotherapy for partial seizures (with or without secondary generalisation) in adults with newly diagnosed epilepsy. Monotherapy is defined as treatment with a single drug.

Already available in Italy 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]

"Monotherapy is the optimal treatment approach for newly diagnosed epilepsy and zonisamide's proven efficacy in this setting will help people with partial epilepsy to control their seizures commented Professor Michel Baulac, Hopital de la Pitie-Salpetriere, Paris, France and lead investigator in the study which resulted in the approval of zonisamide monotherapy in Europe "This treatment, which is easy to titrate and offers the advantage of once daily dosing, may improve adherence to treatment for people with epilepsy."

In Italy, there are approximately 300,000 people with epilepsy and 25,000 new cases are diagnosed every year.^[3] For the majority of people with epilepsy, seizures can be controlled with one AED; however, seizures persist in up to 30% of patients with partial onset epilepsy (the most common form of the condition) despite existing medical therapy.^[4]

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,^[5] 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.

"The availability of Zonegran as monotherapy for adults in Italy is a great step forward, giving newly diagnosed people with epilepsy access to another treatment option," said Giuseppe Lo Presti, Epilepsy Business Unit Director, Eisai Italy. "This class A reimbursement also highlights the commitment of the authorities, the patients' associations and Eisai to providing patients and their families with improved quality of life by bringing effective treatments to those that need it."

In addition to monotherapy, zonisamide is indicated in Europe and reimbursed in Italy as adjunctive therapy in the treatment of partial seizures, with or without secondary generalisation, in adults; zonisamide is also indicated in Europe, but not currently reimbursed in Italy, for the adjunctive treatment of partial seizures, with or without secondary generalisation in adolescents and children aged six years and above.^[1]

The continued development of zonisamide underscores Eisai's human health care 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.^[6]

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 100 mg.^[1]

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

About Epilepsy

Epilepsy is one of the most common neurological conditions in the world.^[7] There are an estimated six million people who live with epilepsy 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 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 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

* Zonegran paediatric indication is not currently reimbursed in Italy

** Zebinix, Fycompa and Inovelon suspension are not currently reimbursed in Italy

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:

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• 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. Associazione Italiana contro l'Epilessia, Epilessia e Crisi, 2013 http://www.aice-epilessia.it/index.php?option=com_content&view=article&id=39&Itemid=27

4. Kwan P, Brodie MJ Early identification of refractory epilepsy. New England Journal of Medicine 2000; 342:314-9

5. 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

6. Glauser T. et al. Updated ILAE evidence review of antiepileptic drug efficacy and effectiveness as initial monotherapy for epileptic seizures and syndromes. 7. 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: October 2013
Job code: Zonegran-UK2513