The US Food and Drug Administration (FDA) has granted approval of Sabril, the first drug approved in the country to treat spasm and seizures in infants.
Sabril (vigabatrin) Oral Solution received approval to treat infantile spasms in children aged one month to two years, a debilitating disorder that usually appears in the first year of life, typically between four and eight months.
The drug’s manufacturer, Danish pharmaceuticals group Lundbeck, plans to launch the drug in the US during the third quarter of 2009.
FDA Centre for Drug Evaluation and Research Division of Neurology Products’ Russell Katz said that these seizures can cause impaired nervous system function and reduced quality of life.
“Infantile spasms in children this young are very serious and this approval provides these patients and their parents with a treatment option,” Katz said.
Sabril was designated as an orphan drug by the FDA as a treatment for a disease or condition that affects fewer than 200,000 people in the US.
Damage to vision is an important safety concern with the use of Sabril, as even the lowest doses can cause vision damage. Because of this the drug will come with a boxed warning to alert healthcare professionals to the risk.