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GMP Inspection Preparation Checklist: A Tool for Internal Auditing

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FDA Releases 25 Product-Specific Guidances for Generics

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EC APPROVES UCB'S KEPPRA

KEYWORDS Daily International Pharma Alert
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The European Commission (EC) has approved Keppra (levetiracetam), manufactured by Belgium-based UCB, as adjunctive therapy in the treatment of myoclonic seizures in adults and adolescents from 12 years of age with juvenile myoclonic epilepsy (JME). The medication is the only newer anti epileptic drug approved in Europe for the treatment of this side-effect of JME.

"Keppra has over one million patient years' experience and continues to help many people with partial-onset seizures," said Troy Cox, president of CNS operations at UCB. "This new indication supports Keppra's established efficacy and we are pleased that Keppra is now available to patients with myoclonic seizures in JME."

JME is a common epilepsy syndrome that usually begins between the ages of 12 and 18 and accounts for approximately 10 percent of all cases of epilepsy. It is characterized by myoclonic jerks that occur in 100 percent of cases, with many patients also experiencing generalized tonic-clonic and absence seizures.