FDA approves Eisai’s BANZEL® as an adjunctive treatment of seizures in kids (Age 1-4) with LGS

Feb. 13, 2015 - PRLog -- The U.S. Food and Drug Administration (FDA) approved supplemental New Drug Application (sNDA) for Eisai’s BANZEL®(rufinamide) to be used as an adjunctive treatment of seizures in pediatric patients one to four years old with Lennox-Gastaut Syndrome (LGS). Banzel is already approved as an adjunctive treatment of seizures linked to LGS in kids age four years and older and adults.

"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 help serve patients and families living with this rare condition."

FDA approval was based on pharmacokinetic bridging study of a Phase III clinical trial (study 303) in patients 1 to 4 years of age.  According to the study the pharmacokinetic and safety profiles are consistent with those seen in ages 4 and above.

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