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UCB receives positive regulatory opinions for seizure treatment
By Lisa Kerner
Erie, Pa., Feb. 3 - UCB said the European Medicines Agency has issued a positive opinion to approve marketing authorization of Keppra (levetiracetam) Concentrate (100 mg/mL) in the treatment of partial onset seizures in adults and children four years of age and older with epilepsy.
Keppra Concentrate is an intravenous administration for use as adjunctive therapy in the treatment of partial onset seizures with or without secondary generalization, according to a company release.
UCB said it also received an approvable letter from the Food and Drug Administration in response to the New Drug Application for Keppra Injection 100 mg/mL for use as adjunctive therapy in the treatment of seizures.
The FDA requested revised product labeling and additional manufacturing information to finalize its review. UCB said it has complied with the request.
"This positive news is an important step in the continuing development of Keppra," UCB chief executive officer Roch Doliveux said in the release.
"This new Keppra formulation will be of help to patients and physicians in emergency seizure situations where oral medication is not an option. When approved by the regulatory authorities, Keppra will become the first of the newer antiepileptic drugs to be available in an intravenous formulation."
Keppra is approved in the United States in tablet and oral solution formulations for adjunctive therapy in the treatment of partial onset seizures in adults and children four years of age and older with epilepsy. The product is approved similarly in Europe.
UCB is a global biopharmaceutical company with its headquarters located in Brussels, Belgium.
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