Banzel rufinamide regulatory update

FDA accepted and granted Priority Review to an sNDA from Eisai for Banzel rufinamide as an adjunct treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in patients ages 1-3 years. The PDUFA date is Feb. 12, 2015.

Eisai markets the triazole derivative in the U.S. as Banzel and in the EU as Inovelon as adjunctive treatment of seizures associated with LGS in patients ages >=4 years. Rufinamide is also approved for the indication in Switzerland and Canada. ...