New US indication for Lundbeck’s Sabril

Danish CNS drug specialist Lundbeck (LUND: CO) says that the US Food and Drug Administration has approved its Sabril (vigabatrin) 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 on the age range of Sabril’s previous indication as adjunctive therapy for adults with refractory CPS. Sabril is not indicated as a first-line agent for refractory CPS.

Of the more than two million Americans affected by epilepsy, around 35% have CPS, which originates from a single region of the brain and can cause impaired consciousness. About 30% to 36% of those with CPS continue to have seizures despite trying multiple therapies, and are considered to have refractory CPS.