EU agency recommends UCB's Keppra for child use
Key points
- Belgian drug maker UCB said on Monday a European committee had approved the use of its Keppra drug on children four years of age and older suffering from epilepsy.
- The Committee for Medicinal Products for Human Use of the European Medicines Agency (EMEA) had issued a positive opinion, recommending approval of the drug as adjunctive therapy in the treatment of partial-onset Seizures, it said in a statement.
- Food and Drug Administration approved the paediatric indication for Keppra under priority review.
- UCB shares were up 1.37 percent at 45.09 euros, by 0823 GMT.
Belgian drug maker UCB said on Monday a European committee had approved the use of its Keppra drug on children four years of age and older suffering from epilepsy.
The Committee for Medicinal Products for Human Use of the European Medicines Agency (EMEA) had issued a positive opinion, recommending approval of the drug as adjunctive therapy in the treatment of partial-onset Seizures, it said in a statement. EMEA would forward the recommendation to the European Commission for review and final decision, which is expected within 90 days, it said.
In June, the U.S. Food and Drug Administration approved the paediatric indication for Keppra under priority review.
UCB shares were up 1.37 percent at 45.09 euros, by 0823 GMT.
Written and revised by
David Cohen, M.D.
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