Japanese pharmaceutical company Eisai has received expanded approval from the US Food and Drug Administration (FDA) for its antiepileptic drug (AED), Banzel (rufinamide) to treat children and infants.
The FDA previously approved Banzel as adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in children aged four years and older, with it now approving the drug for the same indication in paediatric patients from less than one year old up to four.
Rufinamide is a triazole derivative, which is structurally unrelated to currently marketed AEDs. The drug is understood to exercise its antiepileptic effects by regulating activity of voltage-gated sodium channels in the brain involved in the overexcitement of neurons that potentially cause seizures to prolong their inactive state.
The latest approval was based on an interim analysis of a Phase III clinical trial (Study 303) in paediatric patients aged less than one year up to four, comparing Banzel with other existing AEDs as add-on treatments.
According to Eisai, the trial demonstrated that the pharmacokinetic and safety profiles are consistent with those observed in studies conducted so far in patients aged four and above.
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Banzel has received an extension to its marketing exclusivity period, which will be valid to up to May 2023.
In February 2004, Eisai received exclusive worldwide rights from Novartis for rufinamide, to develop, manufacture and market rufinamide for any human therapeutic use excluding bipolar mood disorder, anxiety disorders and ophthalmologic disorders.
It obtained approval as a therapy to other AEDs in treatment of seizures associated with LGS in the European Union in January 2007 as Inovelo and in the US, as Banzel in November 2008.
In Japan, the agent received approval in March 2013 under the brand name Inovelon as an adjunctive therapy to other AEDs in the treatment of tonic and atonic seizures associated with LGS when therapy with other AEDs is considered inadequate.
