FDA approves marketing of Sabril for infantile spasms

Sabril is an oral antiepileptic drug developed by Lundbeck Inc. Besides oral solution designed for infants, the FDA also approved of Sabril in 500 mg tablets as an add-on therapy in complex partial seizures (CPS) in adults who have not benefited from other treatments.

“Infantile spasms in children this young are very serious and this approval provides these patients and their parents a treatment option,” said Russell Katz, M.D., director of the Division of Neurology Products at the FDA’s Center for Drug Evaluation and Research.

"The approval of Sabril is great news for patients and their families who have been waiting a long time for access to this new therapy," said Dr. W. Donald Shields, Director of the Pediatric Epilepsy Program at the University of California at Los Angeles.
He further stated, "Having more than a decade of experience with Sabril, I have felt this drug was important to the epilepsy community. Lundbeck shared my commitment to getting this important therapy approved and without their support, Sabril would not be available today in the U.S.”

Warning about vision loss
According to the FDA, "Damage to vision is an important safety concern with the use of Sabril.” Hence the drug will carry a boxed warning that its usage could lead to progressive loss of peripheral vision depending on the dosage and duration of use.

Further, regular vision testing is recommended for those taking Sabril. Also, because of the risk of permanent vision damage, the company said the approval of the FDA is tied with a Risk Evaluation and Mitigation Strategy.

Due to this, the drug would be available only through a restricted distribution program called Support Help and Resources for Epilepsy.

About infantile spasms
Infantile spasms usually strike infants between ages 4- to 8-months and is characterized by severe seizures, generally arising after a child has eaten or on awakening.

The seizures come about in sets of up to 100 spasms. When the spasms take place, the body of the child suddenly bends forward and their arms and legs stiffen. In some cases, infants arch their backs as they extend their arms and legs.

Numerous reasons are attributed to the disorder, such as birth injury, genetic abnormalities and metabolic problems. However, in some children no cause can be identified by doctors.

It is a rare condition, affecting only one baby in a few thousand. An estimated 8,500 infants in the U.S. have been diagnosed with IS and around 2,500 new cases are reported in the U.S. annually.