Lundbeck gets US FDA backing for Onfi to treat severe type of seizures

Danish drugmaker Lundbeck (LUND: DC) yesterday received approval from the US Food and Drug Administration for Onfi (clobazam) as adjunctive therapy for seizures associated with Lennox-Gastaut syndrome (LGS) in patients two years and older. Onfi will be available in US pharmacies in early January 2012 and is a federally controlled schedule four substance (C-IV), the company said.

LGS is a rare and severe form of epilepsy that is typically diagnosed in childhood and often persists into adulthood. It is associated with multiple types of seizures with periods of frequent seizures, and daily seizures are common. Some of these seizures, including atonic, tonic and myoclonic seizures, may cause falls, or "drop seizures" (also referred to as "drop attacks"), which may result in injury.

Onfi, which has been granted orphan drug status by the FDA, could reach peak sales of $175 million, according to Peter Welford, an analyst at Jefferies International, quoted by Bloomberg.