Eisai Inc. announced that US health regulators expanded approval of Banzel (rufinamide) as an adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome (LGS) in pediatric patients.
The company said that the US Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for Banzel for treatment of LGS in patients from one to four years of age. The drug was initially approved by the agency in 2008, for treatment of seizures associated with LGS in children ages four years and older and adults.
LGS is a rare and severe form of childhood-onset epilepsy that is characterized by frequent seizures, multiple seizure types, a resistance to medication and/or therapies, behavior disturbances and moderate to severe cognitive dysfunction. According to the LGS Foundation, some of the known causes of LGS include brain injury associated with pregnancy or birth, severe brain infections, developmental malformations of the brain, or a history of infantile spasms. However, in roughly 35 percent of cases, no cause can be found. LGS typically appears between the second and sixth year of life. Currently, no cure exists for LGS. Available treatments are aimed at reducing seizures.
“The approval of Banzel for pediatric patients, one to four 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, Chief Clinical Officer (ECL) and President, Neuroscience & General Medicine, PCU Eisai Product Creation Systems, Eisai Inc. “At Eisai, we are committed to our corporate human health care(hhc) mission and are proud to serve patients and families living with this rare condition.”
The expanded approval of Banzel is based on a pharmacokinetic bridging study of the late-stage clinical trial, study 303. The Phase III study demonstrated the pharmacokinetic and safety profiles are consistent with those seen in ages four and above.
Sources: Eisai Inc.; LGS Foundation