Monday, September 25, 2006

Glaxosmithkline:FDA OKs New Indication For Epilepsy Drug

GlaxoSmithKline PLC's (GSK) anti-seizure medicine received approval to treat Primary Generalized Tonic-Clonic, or PGTC, seizures from the Food and Drug Administration.

The U.K. pharmaceutical company said the drug, Lamictal, was approved to treat children age two and older, as well as adults.

GlaxoSmithKline said PGTC seizures are are among the most-serious and most-common type of generalized seizures, occurring in about 20% of patients with epilepsy.

Epilepsy is a recurrent, unprovoked seizure characterized by a change in sensation, awareness, or behavior brought about by an electrical disturbance in the brain.

This is the fifth FDA approval for Lamictal, which has also been approved to treat partial and generalized seizures and can be used as maintenance therapy for adults with bipolar I disorder.

GlaxoSmithKline said the FDA's approval was based on a multicenter trial in pediatric and adult patients, and was shown to be "highly effective" in reducing the frequency of generalized tonic-clonic seizures by 66%.

More recent approvals at Drug Pipeline

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