FDA accepts Lundbeck's clobazam NDA for review

Lundbeck Inc. today announced 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 October 2011. Additionally, Lundbeck announced Onfi™ (pronounced "on-fee") as the proposed U.S. trade name for clobazam.

The NDA submission is based on a clinical development program that evaluated the safety and efficacy of Onfi as add-on therapy in patients with LGS. Positive results from the largest 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.

"The FDA's acceptance for review of the Onfi NDA represents a significant milestone for Lundbeck as we work to improve the lives of people living with epilepsy," said Timothy M. Cunniff, PharmD, vice president of global regulatory affairs at Lundbeck. "We're pleased to be one step closer to providing a new treatment option for people in the U.S. with LGS, a form of epilepsy that severely impacts the health of the patient, often due to the severity of seizures and frequent injuries."

Source: Lundbeck Inc

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