FDA approves Sabril label expansion patients 2 to 10 years old.
Late Friday, January 24, 2020, the Tuberous Sclerosis Alliance (TS Alliance) learned the FDA formally approved Lundbeck’s label expansion for Sabril® (vigabatrin) to now be available to treat refractory complex partial seizures in patients 2 to 10 years old. Previously, Sabril was only approved to treat infantile spasms in infants 1 month to 2 years of age and to treat complex partial seizures for patients 10 years and older. This new label expansion now means there will be no age gap for patients needing critical access to this medication.
TSC community members can download the new label to show insurers the broadened approved age group since the label won’t be immediately available in Sabril’s package insert.
“Two years ago, the 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 & 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 TSC Clinics in the United States and concluded with a paper used as supplemental information for Lundbeck’s application to the FDA for Sabril’s 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.”