The Food and Drug Administration on Friday approved the first drug to treat infantile spasms, a rare disorder that can cause hundreds of seizures per day in children less than a year old.
Sabril is an oral solution from Deerfield, Ill.-based Lundbeck Inc., approved for children between the ages of 1 month and 2 years. Infantile spasms usually occur while babies are eating or waking up, and often come in clusters of up to 100.
"Infantile spasms in children this young are very serious and this approval provides these patients and their parents a treatment option," said the FDA's director of neurology products Russell Katz.
The agency also approved a Sabril tablet to treat epileptic seizures in adults who have not responded to previous treatments. Specifically, the drug is approved for complex partial seizures, which affect about 3 million adults in the U.S.
The drug will carry a boxed warning, the most serious type available, because of risks of vision loss.
According to the FDA, damage to peripheral vision and visual clarity can increase when Sabril is used at higher doses and for a longer period of time.
The FDA approval comes nearly 30 years after the drug's application was first filed with the agency. Originally submitted by Marion Merrell Dow Inc. in 1980, the rights to Sabril passed through several companies before being acquired by specialty drugmaker Ovation Pharmaceuticals in 2004. Ovation decided to push ahead for approval, despite evidence of Sabril's negative side effects, and a panel of FDA advisers unanimously recommended approval in January.
Lundbeck acquired Ovation in March.
Sabril will only be available through a limited distribution program, and patients will be required to take regular vision exams.
Lundbeck is a subsidiary of the Danish firm H. Lundbeck A/S.