Lundbeck, a Denmark-based pharmaceutical company, has obtained the US Food and Drug Administration (FDA) approval for its SABRIL (vigabatrin), an adjunctive treatment option for children 10 and older with refractory complex partial seizures.
The drug will be used as an add-on therapy for the treatment of refractory complex partial seizures (CPS) in children who have inadequately responded to several other treatments.
The company said that the approval expands upon the age range of the drug's previous indication as adjunctive therapy for adults with refractory CPS.
In the US, about two million people are affected by epilepsy, of which 35% have CPS, which originates from a single region of the brain and can cause impaired consciousness.
According to Lundbeck around 30-36% of the CPS affected people, continue to have seizures in spite of trying multiple therapies, and are considered to have refractory CPS.
Sabril was approved in 2009 and a patient registry was formed to gather information on all patients who are prescribed the drug.
In addition to refractory CPS indication, Sabril is also approved for use in children one month to two years of age with infantile spasms if the possible benefit outweighs the potential risk of vision loss.
The prescription drug Sabril is available in 500mg tablets or 500mg packets of powder for oral suspension.
