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FDA Expands Sabril (Vigabatrin) Indication to Include Children With Partial Seizures
The FDA has approved Sabril (vigabatrin, Lundbeck) as add-on therapy for the treatment of refractory complex partial seizures (CPS) in children 10 years of age and older who have inadequately responded to several other treatments and if the possible benefit outweighs the risk of vision loss.
This approval expands the age range of the previous indication for vigabatrin as adjunctive therapy for adults with refractory CPS. The drug is not indicated as a first-line agent for refractory CPS.
Of the more than two million Americans with epilepsy, approximately 35% have CPS, which originates from a single region of the brain and can cause impaired consciousness. Approximately 30% to 36% of those with CPS continue to have seizures despite trying multiple therapies and are considered to have refractory CPS.
In addition to its indication for refractory CPS, Sabril (vigabatrin) is approved for use in infants and toddlers 1 month to 2 years of age with infantile spasms if the possible benefit outweighs the potential risk of vision loss.
Source: Lundbeck; October 28, 2013.