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news.UCB Pharma has filed a supplemental new drug application with the FDA for a pediatric indication for the oral dosage forms of its antiepileptic drug Keppra, as well as a new drug application for an intravenous form of Keppra.
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The pediatric supplemental new drug application (sNDA) proposes expanding the range of the indication to include children down to four years of age.
According to Dr Peter Verdru, senior medical director and head of neurology, psychiatry and clinical development at UCB Pharma, a pediatric Keppra (levetiracetam) indication will offer physicians a key new add-on treatment for children suffering from partial onset seizures.
UCB Pharma also submitted a new drug application (NDA) for an intravenous form of Keppra 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 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 in adults.