FDA Expands Banzel Age Range for Adjunct Tx in Seizures
Eisai announced that the Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for Banzel (rufinamide) as adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome (LGS) in pediatric patients aged 1–4 years old.
Banzel was initially approved in November 2008 as adjunctive treatment of seizures associated with LGS in pediatric patients aged ≥4 years old and in adults. Banzel is a triazole derivative that is structurally unrelated to currently available antiepileptic drugs. It is believed to exert its effect by regulating the activity of sodium channels in the brain which carry excessive electrical charges that may cause seizures.
The FDA's expanded approval is based on the pharmacokinetic bridging study called Study 303, a Phase 3 clinical trial that showed comparable pharmacokinetic and safety profiles with those observed in patients aged ≥4 years old.
Banzel is available as 200mg and 400mg strength tablets in 120-count bottles, and as a 40mg/mL oral suspension in 460mL bottles.
For more information call (888) 274-2378 or visit Banzel.com.