FDA Okays Vigabatrin as Add-on for Seizures in Children

Susan Jeffrey

November 01, 2013

The US Food and Drug Administration (FDA) has approved vigabatrin (Sabril, Lundbeck) as add-on therapy for the treatment of refractory complex partial seizures (CPS) in children aged 10 years and older who are refractory to several other treatments if the possible benefit outweighs the risk for vision loss with this drug.

Vigabatrin is already approved as adjunctive therapy for adults with refractory CPS, a statement from Lundbeck notes, but it is not indicated as a first-line agent for this indication. It is also approved for use in infants from 1 month to 2 years of age with infantile spasms, again if the possible benefit outweighs the potential risk for vision loss.

The drug was approved in 2009, and a patient registry was established at that time to collect data on patients prescribed vigabatrin. More than 5600 patients have been treated to date, a "substantial number" of whom have been treated for refractory CPS, the company notes. The drug is available in 500-mg tablets or 500-mg packets of powder for oral suspension.

Because of the risk for permanent vision loss, vigabatrin is available only through a restricted program under a risk evaluation and mitigation strategy called the SHARE Program (1-888-45-SHARE).

"With so many children still having seizures due to refractory CPS, we are very pleased that the FDA has approved Sabril for patients 10 and older who may benefit from a new add-on treatment option," said Amy Magro, director of epilepsy marketing at Lundbeck.


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