Danish pharmaceutical firm Lundbeck has received approval from the US Food and Drug Administration (FDA) for its epilepsy drug, Sabril (vigabatrin), to be used in children aged ten years and older.
Sabril has been approved 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 latest approval expands upon the age range of Sabril’s previous indication as adjunctive therapy for adults with refractory CPS and the drug is not indicated as a first-line agent for refractory CPS.
About two million people in the US are affected by epilepsy, with 35% having CPS, which originates from a single region of the brain and can cause impaired consciousness.
According to the company around 30%-36% of those people with CPS continue to have seizures in spite of trying multiple therapies, and are considered to have refractory CPS.
Epilepsy Foundation president and CEO Philip Gattone said: "It is crucially important for people with challenging seizures like refractory CPS to not give up and continue striving for improved seizure management, and this expanded Sabril indication provides another consideration for the treatment of those ten and older with refractory CPS."
Sabril is an antiepileptic drug and a selective, irreversible enzyme-activated GABA transaminase inhibitor.
It was approved in 2009 and a patient registry was formed to gather data on all patients who were prescribed the drug.
Since the initial approval, more than 5,600 patients were treated with the drug, a substantial number of whom have been treated for refractory CPS.
As it carries the risk of permanent vision loss, Sabril is available only through an FDA-mandated Risk Evaluation and Mitigation Strategy (REMS), which specifies elements to manage the risk of permanent vision loss including a special restricted distribution programme called SHARE (Support Help and Resources for Epilepsy).
A comprehensive patient and physician support programme, SHARE is designed to provide tools and resources for all of Lundbeck’s epilepsy products, including Sabril.
Lundbeck director of epilepsy marketing Amy Magro said the FDA approval of Sabril for patients aged ten and older might benefit from a new add-on treatment option.
"For those caring for a child as young as ten, we hope this new indication provides encouragement to speak with their child’s doctor about the risks and potential benefits of adding SABRIL for refractory CPS," Magro said.
Along with refractory CPS indication, the drug 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 medicine Sabril is available in 500mg tablets or 500mg packets of powder for oral suspension.