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news.UCB has received an approvable letter from the FDA requesting more information before the regulators will approve the company's marketing application for an intravenous version of its epilepsy drug Keppra.
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The company submitted a new drug application to the FDA seeking approval for the intravenous administration of the drug in adjunctive therapy for the treatment of partial onset epileptic seizures.
In the approvable letter, the FDA has requested revised product labeling as well as some additional information regarding manufacturing to finalize its review. UCB says that it has already submitted the requested information to the FDA, but the approvable letter will constitute a delay in the drug’s path to market.
In Europe, Keppra has been recommended for approval by an advisory committee to the European Medicines Agency (EMEA). The recommendation to the European regulators makes marketing approval for the drug in Europe likely but not guaranteed.
“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,” said Roch Doliveux, CEO.