Lundbeck seeks FDA approval of epilepsy drug

By Bruce Japsen
Posted March 4 at 8:14 a.m.

Lundbeck Inc. said the U.S. Food and Drug Administration will review its experimental drug for a rare epilepsy disorder.

Deerfield-based Lundbeck, the U.S. subsidiary of Denmark’s H. Lundbeck SA, said the drug, clobazam, is a therapy used to treat “seizures associated with Lennox-Gastaut syndrome in patients two years and older.” Known as “LGS,” the disease is typically diagnosed in childhood, the company said. Lundbeck hopes to eventually market the drug here under the trade name Onfi.

Lundbeck said it expects a “standard” FDA review, which means the agency could approve the drug within the year, agency observers say.

“The FDA’s acceptance for review of the Onfi (new drug application) represents a significant milestone for Lundbeck as we work to improve the lives of people living with epilepsy,” said Lundbeck’s vice president of global regulatory affairs, Timothy Cunniff. “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.”

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