FDA grants priority reviews for Eisai's for rufinamide and lenvatinib

There was good news for Japanese drugmaker Eisai (TYO: 4523) yesterday, as the US Food and Drug Administration granted priority review for two of the companies products.

Firstly, the FDA accepted Eisai’s supplemental New Drug Application (sNDA) for Banzel (rufinamide) and granted it priority review designation as an adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in pediatric patients from one to four years of age. Banzel, also marketed under the Inovelon trade name, is indicated for the adjunctive treatment of seizures associated with LGS in children four years and older and adults.

The priority review designation was assigned to this sNDA because the FDA requested this pediatric data under the Best Pharmaceuticals for Children Act.