FDA approves Lundbeck's Sabril in children

Drug approved for treating complex partial seizures in children ages 10 years and older

DEERFIELD, Ill. — The Food and Drug Administration has approved a drug made by Lundbeck for treating a form of epilepsy in children, the drug maker said.

Lundbeck announced the approval of Sabril (vigabatrin) as an add-on therapy for refractory complex partial seizures in children ages 10 years and older who have not responded adequately to other treatments, as long as the benefit of treatment outweighs the risk of vision loss. The drug was already approved for treating the same condition in adults in 2009.

CPS affects about 35% of the more than 2 million Americans with epilepsy. CPS originates from from a single region of the brain and can cause impaired consciousness, and about 30% to 36% of those with it continue to have seizures despite trying multiple drug therapies, according to medical research.

 

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