Lundbeck Inc. (“Lundbeck”), a wholly owned subsidiary of H. Lundbeck A/S in Denmark (Copenhagen: LUN), announced today that the U.S. Food and Drug Administration (FDA) has granted two New Drug Application (NDA) approvals for Sabril® (vigabatrin) Tablets and Oral Solution. Lundbeck plans to launch Sabril in the United States in the third quarter.
Sabril is indicated as monotherapy for pediatric patients one month to two years of age with infantile spasms (IS) for whom the potential benefits outweigh the potential risk of vision loss, and as adjunctive (add-on) therapy for adult patients with refractory complex partial seizures (CPS) who have inadequately responded to several alternative treatments and for whom the potential benefits outweigh the risk of vision loss.1,2 Sabril is not indicated as a first line agent for CPS.
Sabril causes permanent bilateral concentric visual field constriction in 30 percent or more of patients that ranges in severity from mild to severe, including tunnel vision to within 10 degrees of visual fixation and can result in disability. In some cases, Sabril also can damage the central retina and may decrease visual acuity. Sabril causes permanent vision loss in infants, children and adults. The onset is unpredictable and can occur within weeks of starting treatment, or sooner, or at any time during treatment, even after months or years. Because of this risk of permanent vision loss, Sabril approval is accompanied by an FDA-mandated Risk Evaluation and Mitigation Strategy (REMS) and is available only through a special restricted distribution program called SHARE (Support Help and Resources for Epilepsy).
Sabril is the first therapy approved for the treatment of IS and an important new option as add-on therapy for the approximately 30 to 36 percent of adults with CPS whose seizures remain uncontrolled in spite of having many antiepileptic therapies already available.3,4
“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. “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.”