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news.Japanese pharmaceutical firm Eisai's US subsidiary has secured approval from the Food and Drug Administration (FDA) for an additional pediatric indication for its antiepileptic drug (AED) Banzel (rufinamide) to treat seizures associated with Lennox-Gastaut syndrome (LGS).
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Banzel is a triazole derivative, which is structurally unrelated to currently marketed antiepileptic drugs.
Earlier, the FDA had approved Banzel as adjunctive treatment of seizures associated with LGS in children aged four years as well as adults.
With the new approval, Banzel is now additionally approved for the same indication in pediatric patients from one to less than four years of age in the US.
The latest approval is based on an interim analysis of a Phase III clinical trial (Study 303) conducted in paediatric patients from one to less than four years of age, comparing Banzel with other existing AEDs as add-on treatments.
The trial showed that the pharmacokinetic and safety profiles are consistent with those observed in trials conducted so far in patients aged four and above.
The drug has also received an extension to its marketing exclusivity period, which will be valid to up to May 2023.