The Food and Drug Administration (FDA) has expanded the approval of Sabril® (vigabatrin; Lundbeck) to include treatment of refractory complex partial seizures (CPS) in pediatric patients aged 2 to <10 years of age who have inadequately responded to several alternative treatments and for whom the potential benefits outweigh the risk of vision loss. Previously, the treatment had only been approved for CPS in patients 10 years of age and older.
The approval was based on data from 3 randomized, double-blind, placebo-controlled, parallel-group, adjunctive-treatment studies in patients aged 3-16 years with uncontrolled CPS with or without secondary generalization (N=373). Data from these studies were pooled and used in a pharmacometric bridging analysis, which consisted of defining a weight-normalized dose response, and showing that a similar dose response relationship exists between pediatric patients and adult patients when Sabril® was given as adjunctive therapy. The dosing recommendations in pediatric patients 2 to 16 years of age were derived from simulations using these pharmacometric dose-response analyses.
Commenting on the approval, Darcy Krueger, MD, PhD, Director of the Cincinnati Children’s Hospital Medical Center Tuberous Sclerosis Complex (TSC) Clinic, said: “Vigabatrin has been used safely for many years…yet patients were having difficulty getting medication approved by their insurance because the previous FDA approval didn’t include patients aged 2 to 10. 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.”
With regard to safety, among pediatric patients with CPS, weight gain was observed to be the most common adverse reaction. Sabril® carries a Boxed Warning regarding the risk of permanent vision loss. Because of this risk, the drug is only available through a restricted distribution program called the Vigabatrin REMS Program.
Sabril® is also indicated for use as monotherapy for pediatric patients 1 month to 2 years of age with infantile spasms for whom the potential benefits outweigh the potential risk of vision loss.
For more information visit sabril.net.