Swissmedic Approves Zonegran® (zonisamide) Monotherapy Treatment for Epilepsy

HATFIELD, England, July 11, 2013 /PRNewswire/ --

Zonegran^® (zonisamide) has today been approved by Swissmedic, the Swiss agency for the authorisation and supervision of therapeutic products, for the monotherapy treatment of partial seizures (with or without secondary generalisation) in adults with newly diagnosed epilepsy. Monotherapy is when treatment is given with one single drug.

Already a successful add-on therapy, once-daily zonisamide is a second generation anti-epileptic drug (AED) with multiple mechanisms of action and a chemical structure which is unrelated to any other AEDs.^[1] For patients with newly diagnosed epilepsy, monotherapy is the preferred option for managing their condition as this reduces the potential for adverse drug interactions and encourages treatment compliance.^[2]

"Monotherapy is the optimal treatment approach for managing epilepsy and therefore the availability of zonisamide in this setting will provide newly diagnosed epilepsy patients with access to this already proven treatment as a first-line option in their care pathway," commented Professor Michel Baulac, Head of Neurology, Université Paris VI.

Epilepsy is one of the most common neurological conditions in the world^[3] with an estimated 70,000 people living with the condition in Switzerland alone^[4]. The successful treatment of partial-onset seizures (the most common type of epilepsy) remains a significant challenge and up to 30% of patients fail to achieve seizure freedom with existing AEDs^[5].

"The approval of zonisamide monotherapy in Switzerland is a very welcome advance for both doctors and patients. The new extended monotherapy indication for Zonegran will provide patients with an alternative option to help improve their seizure control. The monotherapy indication will become an increasingly important option in the early treatment of partial epilepsy," said Dr. Christiane Kordeuter, Medical Director, Eisai Switzerland. "Zonegran is one of only six AEDs available as monotherapy, allowing doctors to tailor treatment to individual patient needs."

The efficacy and safety of zonisamide as monotherapy has been 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. 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 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 well being of people worldwide. Eisai is committed to the therapeutic area of epilepsy and addressing the unmet medical needs of patients with epilepsy and their families. Eisai is proud to currently market more epilepsy products in EMEA than any other company.

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. In addition, zonisamide is also indicated as adjunctive therapy in the treatment of partial seizures (with or without generalisation) in adults with epilepsy. 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. In the first two weeks, the recommended daily dose for monotherapy use is 100mg/day. In the third and fourth weeks the dose may be increased to 200 mg daily and then increased to 300mg daily after the next two weeks.^[1]

For more information please visit: http://www.eisai.co.uk

About Epilepsy

Epilepsy is one of the most common neurological conditions in the world, affecting approximately eight in 1,000 people in Europe,^[8] and an estimated 50 million people worldwide.^[3] 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, Russia and Oceania (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

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 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, the Middle East and Russia.

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

References

1. Zonegran Summary of Product Characteristics [http://emc.medicines.org.uk ] January 2013, http://www.swissmedicinfo.ch

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-epilepsy.org/Visitors/Documents/EUROReport160510.pdf (Accessed June 2011)

4. EPI Swiss Epilepsy Centre. Available at: http://www.swissepi.ch/web/swe.nsf/swe__swebasdocs/epi_klinik_kurzinfo_englisch?OpenDocument (Accessed August 2011)

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

6. Baulac, 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. 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: July 2013

Job code: Zonegran-EU0033