The US Food and Drug Administration (FDA) has granted an additional paediatric indication approval for Eisai Inc's antiepileptic drug (AED) Banzel (rufinamide).
Through this approval, Banzel, which had been approved for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in children four years older and adults, is now additionally approved for the same indication in paediatric patients from one to less than four years of age in the United States.
The additional indication approval is based on an interim analysis of a phase III clinical trial (Study 303) in paediatric patients from one to less than four years of age comparing Banzel with other existing AEDs as add-on treatments. The study showed that the pharmacokinetic and safety profiles are consistent with those seen in studies conducted so far in patients ages four and above. The most frequently reported adverse reactions in the Banzel treatment group were vomiting and somnolence.
Furthermore, as the FDA has acknowledged that the clinical trial data meets its written request for pediatric studies under the Best Pharmaceuticals for Children Act, Banzel was granted an extension to its marketing exclusivity period, which will potentially continue until May 2023.
LGS is a severe form of epilepsy that affects 1 to 4 per cent of all US children with epilepsy. Characterised by multiple seizure types, the disorder is extremely difficult to control, with patients normally having to take several different AEDs. The most common seizure types associated with LGS, tonic and atonic seizures, lead to frequent falls due to sudden loss of consciousness. LGS often causes delayed intellectual development and behavioral disturbances, and therefore has a significant impact on the quality of life of both patients and their families. Banzel is a triazole derivative that is structurally unrelated to currently marketed AEDs. It is believed to exert its effect by regulating the activity of voltage-gated sodium channels in the brain involved in the overexcitement of neurons that potentially causes seizures.
Eisai considers epilepsy a therapeutic area of focus and has been marketing rufinamide in over 20 countries in Europe, the Americas and Asia as well as Japan. By enhancing its drug development capabilities in the field of epilepsy and providing multiple treatment options as part of an extensive epilepsy product portfolio, Eisai seeks to make further contributions to address the diversified needs of, and increase the benefits provided to, epilepsy patients and their families.