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New Indication and Formulation Filed for Levetiracetam

SMYRNA, Ga., Dec. 22 /PRNewswire/ -- UCB Pharma, Inc., today announced that it filed a supplemental new drug application (sNDA) with the U.S. Food and Drug Administration (FDA) for a pediatric indication for the oral dosage forms of its antiepileptic drug Keppra(R) (levetiracetam), as well as a new drug application (NDA) for an intravenous form of Keppra(R).

"These applications reflect the proven efficacy, ease of use and tolerability of Keppra(R) for treating a variety of special populations," said Peter Verdru, M.D., senior medical director and head, Neurology, Psychiatry and Clinical Development, UCB Pharma. The pediatric sNDA proposes expanding the range of the indication to include children down to four years of age. "A pediatric indication for Keppra(R) (levetiracetam) will provide physicians with an important new add-on treatment option for children with partial-onset seizures," said Dr. Verdru.

About 300,000 American children under the age of 14 have epilepsy(1). For some, it will be a temporary problem, likely controlled with medication and outgrown after a few years. For others, it may be a lifelong challenge affecting many areas of life(2). Medications are usually the first-line treatment for children with epilepsy.

UCB Pharma, Inc., also submitted a new drug application for an intravenous form of Keppra(R) (levetiracetam) for adjunctive therapy in the treatment of partial onset seizures in adults with epilepsy when oral administration is temporarily not feasible. "An approval of Keppra(R) for intravenous administration," Dr. Verdru noted, "will provide an important new add-on option for treating partial seizures in a hospital setting."

The safety profile demonstrated in these clinical trials was similar to the currently known safety profile of oral Keppra(R) in adults.

About Keppra(R)
Keppra(R) is indicated as adjunctive therapy in the treatment of partial onset seizures in adults with epilepsy. Keppra(R) is available in 250, 500 and 750 mg tablets and a grape-flavored (100 mg/mL) oral solution for patients who prefer a solution or have difficulty swallowing tablets. Taken with or without food, the effective recommended starting dose of Keppra(R) is 1,000 mg/day given twice daily (500 mg bid). Since its launch, Keppra(R) has had more than 500,000 unique patient starts in the United States(3) and is the most prescribed second-generation AED used in adults with epilepsy.(4)

Keppra(R) use is associated with the occurrence of central nervous system adverse events, including somnolence and fatigue, coordination difficulties, and behavioral abnormalities as well as hematological abnormalities. Keppra(R) dosing must be individualized according to renal function status. In well-controlled clinical studies, the most frequently reported adverse events associated with the use of Keppra(R) in combination with other AEDs, not seen at an equivalent frequency among placebo-treated patients, were somnolence, asthenia, infection and dizziness.

About Epilepsy
Epilepsy is the most common neurological disorder, estimated to affect 50 million people worldwide(5) and 2.5 million Americans.(6) The disease can strike at any time, but has the highest incidence in individuals under age two and over 65. In the U.S., 181,000 new cases of epilepsy are diagnosed each year. Up to 80 percent of people with epilepsy can gain full or partial control of their seizures with treatments such as anti-epileptic drugs.(7) Surgery, the ketogenic diet or an implanted device that delivers electrical stimulation to the brain are other treatment options.

References
(1) Epilepsy Foundation. Answer Place: Life Aspects: Children. Available at: http://www.epilepsyfoundation.org/answerplace/Life/children.
(2) Epilepsy Foundation. Epilepsy: A Spectrum of Severity. Available at: http://www.epilepsyfoundation.org/answerplace/severity.cfm. Accessed on December 14, 2004.
(3) Available from: Verispan Retail Pharmacy Database. Accessed May 2004.
(4) Available from: IMS Health, National Disease and Therapeutic Index(TM). Accessed Oct 2004; Based on an intent-to-treat (ITT) analysis; when generalized seizures were specified, the data were excluded from this analysis.
(5) The World Health Report 2001, "Mental Health: New Understanding, New Hope" World Health Organization, available at: http://www.who.int/whr2001/2001/main/en/chapter2/002e4.htm. Accessed on December 14, 2004.
(6) Epilepsy Foundation. Epilepsy and Seizure Statistics. Available at: http://www.epilepsyfoundation.org/answerplace/statistics.cfm. Accessed on December 14, 2004.
(7) Epilepsy Foundation. Epilepsy: A Spectrum of Severity. Available at: http://www.epilepsyfoundation.org/answerplace/severity.cfm. Accessed on December 14, 2004.

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