FDA approves Banzel for Lennox-Gastaut Syndrome in pediatric patients-Eisai

The FDA has approved a supplemental New Drug Application (sNDA) for Banzel (rufinamide), from Eisai, as an adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome (LGS) in pediatric patients from one to four years of age.

Approval is based on a pharmacokinetic bridging study of a Phase III clinical trial (study 303) which demonstrated the pharmacokinetic and safety profiles are consistent with those seen in ages 4 and above. In this study, comparing Banzel (45 mg/kg per day) adjunctive treatment (n=25) to the adjunctive treatment with an AED of the investigator's choice (n=11) in pediatric patients (1 year to less than 4 years of age) with inadequately controlled Lennox-Gastaut Syndrome, the adverse reaction profile was generally similar to that observed in adults and pediatric patients 4 years of age and older treated with Banzel.

Adverse reactions that occurred in at least 2 (8%) Banzel-treated patients and with a higher frequency than in the AED comparator group were: vomiting (24%), somnolence (16%), bronchitis (12%), constipation (12%), cough (12%), decreased appetite (12%), rash (12%), otitis media (8%), pneumonia (8%), decreased weight (8%), gastroenteritis (8%), nasal congestion (8%), and pneumonia aspiration (8%).

Comment: Banzel was first approved by the FDA in November 2008, for the adjunctive treatment of seizures associated with LGS in children ages four years and older and adults.