Sabril Label Expanded for Patients 2 to 10 Years Old

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On January 24, the Tuberous Sclerosis Alliance (TS Alliance) learned the US Food and Drug Administration (FDA) formally approved Lundbeck Pharmaceutical'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, particularly those in the tuberous sclerosis complex (TSC) community.

"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," said 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 Darcy Krueger, MD, PhD, Director of the Cincinnati Children's Hospital Medical Center TSC Clinic. 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.

"Vigabatrin has been used safely for many years to treat both infantile spasms and partial seizures, yet patients were having difficulty getting medication approved by their insurance because the previous FDA approval didn't include patients aged 2 to 10," Dr. Krueger explained. "We were able to work with TSC Clinics like ours with considerable experience treating children in this age range to collect safety and efficacy data so it could be included in the FDA's new review. We are happy to learn the FDA updated the indication so TSC patients of any age can obtain the medication when recommended by their neurologists."

An updated Sabril label can be downloaded at www.tsalliance.org/sabril-change to show insurers the broadened approved age group since the label won't be immediately available in the medication's package insert.

"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."

"All of us at Lundbeck couldn't be more pleased to have secured approval for this important label change — an outcome that closes an important gap and speaks to Lundbeck's enduring commitment to doing what's right for patients," said Sally Benjamin Young, Vice President, Public Affairs at Lundbeck. "What a proud moment for us to be able to have so crucial an impact on this community."