FDA Approves Expanded Indication for Vigabatrin

The Food and Drug Administration has approved expanded indications on the label for vigabatrin (Sabril, Lundbeck, Deerfield, IL) to treat refractory complex partial seizures in individuals age 2 to 10 years. This new label expansion now means there will be no age gap for individuals needing critical access to this medication. Previously, vigabatrin was only approved to treat infantile spasms in infants ages 1 month to 2 years and to treat complex partial seizures for individuals 10 years and more. 

Anyone can download the new label to show insurers the broadened approved age group.

“Two years ago, the Tuberous Sclerosis Alliance (TS Alliance) became aware insurance companies were denying coverage for vigabatrin for our community members whose children were 3 to 9 years old,” explained Kari Luther Rosbeck, president and CEO. “We reached out to Lundbeck to begin discussing how to address this gap utilizing, at that time, recently released global guidance for complex partial seizure medications with the ability to extrapolate efficacy information down to age 3.”

These discussions eventually resulted in the TS Alliance funding a study led by Dr. Darcy Krueger of Cincinnati Children’s Hospital Medical Center. This study included 198 medical chart reviews by 13 clinics treating children with tuberous sclerosis complex (TSC) in the US, and study publication was used as supplemental information on the application to the FDA for a label expansion.

“This new FDA approval is a game-changer for the TSC community, and we are incredibly grateful to our partners at Lundbeck who understood the need and worked diligently to obtain this label change for patients,” Rosbeck said. “We are also thankful to Dr. Krueger and all the TSC Clinics who participated in the study as well as our chief scientific officer Steven Roberds, PhD, who worked closely on the study.”