The FDA today approved a supplemental New Drug Application for Eisai's rufinamide (Banzel) as an adjunctive treatment for seizures associated with Lennox-Gastaut Syndrome in pediatric patients aged 1 to 4 years.
The FDA today approved a supplemental New Drug Application (sNDA) for Eisai’s rufinamide (Banzel) as an adjunctive treatment for seizures associated with Lennox-Gastaut Syndrome (LGS) in pediatric patients aged 1 to 4 years.
Banzel was previously approved for this purpose exclusively in patients aged >4 years.
The FDA based its nod on a pharmacokinetic bridging study of a phase 3 clinical trial which demonstrated that Banzel’s safety and efficacy in patients aged 1 to 4 years were consistent with what was observed in patients aged >4 years.
“The approval of Banzel for pediatric patients, 1 to 4 years of age, represents an important milestone, as it may help to address an unmet need of younger patients with Lennox-Gastaut Syndrome," said Lynn Kramer, president of Eisai’s Neuroscience & General Medicine Production Creation Unit and chief clinical officer of Eisai Product Creation Systems, in a press release. “At Eisai, we are committed to our corporate human health care mission and are proud to help serve patients and families living with this rare condition.”
Common adverse events experienced by trial subjects treated with Banzel include vomiting, somnolence, bronchitis, constipation, cough, decreased appetite, rash, otitis media, pneumonia, decreased weight, gastroenteritis, nasal congestion, and pneumonia aspiration.