Zonegran® (Zonisamide) Approved for Use in Children and Adolescents by Scottish Medicines Consortium (SMC)

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Eisai Europe Limited

10 Mar, 2014, 00:01 GMT

HATFIELD, England, March 10, 2014 /PRNewswire/ --

Zonegran® (zonisamide) has been approved by the Scottish Medicines Consortium (SMC) for the treatment of partial epilepsy in adolescents and children aged six years and above in Scotland.[1] This decision follows zonisamide's paediatric license extension approval by the European Commission (EC) on 3 October 2013.

Already available in Scotland as adjunctive therapy for the treatment of partial seizures, with or without secondary generalisation, in adults, zonisamide is a second generation anti-epileptic drug (AED) with multiple mechanisms of action and a chemical structure unrelated to any other AEDs.[2]

"Uncontrolled epilepsy can affect all aspects of children and their family's lives and so new, effective and well tolerated medications are always needed," commented Professor Martin Brodie, Director of the Epilepsy Unit at the Western Infirmary in Glasgow. "My extensive experience of treating adults with zonisamide in Scotland has demonstrated its effectiveness in reducing partial onset seizures[3] and I look forward to seeing this opportunity extended to children and adolescents."

Epilepsy is one of the most common neurological diseases and affects around 54,000 people in Scotland.[4] Across the United Kingdom around 63,400 children and young people aged 18 years and under have epilepsy.[5] The successful treatment of partial onset seizures (the most common type of epilepsy) remains a challenge with more than 30% of people not able achieve seizure control with current treatments.[6]

"We are delighted that Zonegran can now be prescribed for children in Scotland," commented Patrick Standen, EMEA Brand Director, Eisai Europe Ltd. "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."

The zonisamide paediatric approval in Scotland was based on Study 312 (CATZ) published in Epilepsia in July 2013.[7] These data from a double-blind, randomised, multicentre, placebo-controlled Phase III study, showed that that significantly more patients aged six to 17 responded positively to treatment with zonisamide (50%) versus treatment with placebo (31%),[7] Safety and tolerability assessments showed that the overall incidence of treatment-emergent adverse events (TEAEs) was similar for zonisamide versus placebo and that there were low rates of serious TEAEs in both groups.[7]

Zonisamide was approved in Europe in 2005 as an adjunctive therapy in the treatment of partial seizures, with or without secondary generalisation, in adults. In July 2012, the EC approved zonisamide as monotherapy in the treatment of partial seizures, with or without secondary generalisation, in adults with newly diagnosed epilepsy.[2]

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.[2] 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.[2] Zonisamide is one of only four AEDs with level A efficacy/effectiveness evidence as initial monotherapy for adults with partial onset seizures.[8]

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 100mg daily and thereafter the dose may be increased at weekly intervals, in increments of up to 100mg.[2]

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 one in every one hundred people in Europe, and an estimated 50 million people worldwide.[9],[10] 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:

  • 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
  • Inovelon® (rufinamide) for the adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome in patients ≥4 years. (Rufinamide was originally developed by Novartis)
  • Zebinix® (eslicarbazepine acetate) as adjunctive therapy in adult patients with partial onset seizures, with or without secondary generalisation. (Zebinix is under license from BIAL)
  • 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)

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 management
  • 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. Scottish Medical Consortium advice on Zonegran
  2. Eisai Ltd 2013. Zonegran summary of product characteristics (last updated October 2013) https://www.medicines.org.uk/emc/medicine/16240/SPC/Zonegran+25%2c+50%2c+100+mg+Hard+Capsules/
  3. Stephen LJ, et al. A prospective audit of adjunctive zonismade in an everyday clinical setting. Epilepsy & Behavior. 2010:17;455-460
  4. Epilepsy Scotland Facts and figures available at: http://www.epilepsyscotland.org.uk/facts-and-figures/info_96.html. (Accessed 09 January 2014).
  5. Joint Epilepsy Council of the UK and Ireland. Epilepsy prevalence, incidence and other statistics. September 2011
  6. Brodie MJ. et al. Patterns of treatment response in newly diagnosed epilepsy. Neurology 2012:78;1548-1554
  7. Guerrini R. et al. A randomized phase III trial of adjunctive zonisamide in pediatric patients with partial epilepsy. Epilepsia 2013 Aug;54(8):1473-80
  8. Glauser T. et al. Updated ILAE evidence review of antiepileptic drug efficacy and effectiveness as initial monotherapy for epileptic seizures and syndromes. Epilepsia 2013 Mar;54(3):551-63
  9. Pugliatti M et al. Estimating the cost of epilepsy in Europe: A review with economic modeling. Epilepsia 2007:48(12)2224-2233.
  10. Epilepsy in the WHO European Region
    http://www.ibe-epilepsy.org/downloads/EURO%20Report%20160510.pdf [Accessed 10 April 2012].

Date of preparation: February 2014
Job code: Zonegran-UK2519