FDA accepts Lundbeck's submission of the New Drug Application for clobazam
H. Lundbeck A/S announced that the U.S. Food and Drug Administration (FDA) has accepted for review a New Drug Application (NDA) for the investigational compound clobazam as adjunctive therapy in treating seizures associated with Lennox-Gastaut syndrome (LGS) in patients two years and older. The filing was assigned a standard review and an action letter is anticipated in the fourth quarter 2011. Additionally, Lundbeck announced Onfi(TM) as the proposed trade name for clobazam in the US.
The NDA submission is based on a clinical development program that evaluated the safety and efficacy of OnfiTM as add-on therapy in patients with LGS. Positive results from the largest clinical phase III trial ever conducted in patients with LGS were presented at the December 2010 annual meeting of the American Epilepsy Society (AES).
LGS is a rare and severe form of epilepsy that is typically diagnosed in childhood and often persists into adulthood. Most patients with LGS experience multiple types of seizures with periods of frequent seizures, and daily seizures are common. Some of these seizures may cause falls, or "drop seizures," which may result in injury.
Other news from the department research and development
