FDA approves new indication for GSK's Lamictal

Published: 26-Sep-2006
Regulatory

The US Food and Drug Administration (FDA) has approved a new use of the anti-seizure medicine Lamictal (lamotrigine) for the treatment of one of the most serious forms of epilepsy.


The US Food and Drug Administration (FDA) has approved a new use of the anti-seizure medicine Lamictal (lamotrigine) for the treatment of one of the most serious forms of epilepsy.

Lamictal tablets can now be used as add-on therapy to treat Primary Generalized Tonic-Clonic (PGTC) seizures, also known as "grand mal" seizures in children aged two and older as well as adults.

GSK said the new use marks the fifth FDA approval for Lamictal in epilepsy, making it one of the few antiepileptic drugs with established efficacy in a broad spectrum of seizure types, including partial and generalised seizures. Lamictal is also approved as maintenance therapy for adults with bipolar I disorder.

PGTC seizures are the most common type of generalised seizures, occurring in approximately 20% of patients with epilepsy. There have been very few new medications approved for use in primary generalised tonic-clonic seizures, making this approval particularly useful.

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