FDA approves new indication for Lundbeck’s Sabril

Patients two to 10 years and older with refractory complex partial seizures have a new treatment option, now that the Food and Drug Administration has cleared Lundbeck’s Sabril (vigabatrin) for this new indication.

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.

"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, Lundbeck’s vice president of public affairs. "What a proud moment for us to be able to have so crucial an impact on this community."

The Tuberous Sclerosis Alliance applauded the new label expansion, stating that it now means there will be no age gap for patients needing critical access to this medication, particularly those in the 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, TS Alliance 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."

Rosbeck added, "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.