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Published on 24 August 2009

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FDA grants marketing approval for Lundbeck’s Sabril

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Lundbeck today announced that the US Food and Drug Administration (FDA) has granted two New Drug Application (NDA) approvals for Sabril (vigabatrin) tablets and oral solution.

Lundbeck Inc plans to launch Sabril in the US during the third quarter of 2009, with an extensive Risk Evaluation and Mitigation Strategy (REMS) program as required by the FDA and created in collaboration with the agency.

Sabril is the first therapy approved by the FDA for the treatment of infantile spasms (IS) and an important new adjunctive therapeutic option for the approximately 30 to 36 percent of adults with complex partial seizures (CPS) whose seizures remain uncontrolled in spite of having many antiepileptic therapies already available.

Sabril is indicated as monotherapy for paediatric patients one month to two years of age with IS for whom the potential benefits outweigh the potential risk of vision loss. IS is characterised by spasms that may occur in clusters of up to 100 at a time. Sabril represents the only treatment approved by the FDA to help manage this difficult-to-treat condition.

Sabril is also indicated as adjunctive therapy for adult patients with refractory CPS who have inadequately responded to several alternative treatments and for whom the potential benefits outweigh the risk of vision loss. Sabril is not indicated as a first-line agent for CPS. This patient group is inherently difficult to treat and is in need of additional treatment alternatives to help reduce the number of seizures.

Commenting on the approval of the lead compound in its CNS pipeline, Ulf Wiinberg, President and CEO at Lundbeck said: “Infantile spasms and refractory complex partial seizures in adults are difficult-to-treat epilepsies and we are pleased to be able to address the unmet medical need patients with infantile spasms have faced and to offer an additional choice in treating refractory complex partial seizures. FDA approval of Sabril is an important step forward for the entire epilepsy community and provides patients with a new treatment option that could reduce seizures among these adult patients and may eliminate spasms in a certain proportion of children with infantile spasms.”

Lundbeck has together with the FDA established a comprehensive REMS to manage the risk of permanent vision loss associated with the product. The Sabril REMS, which was a critical component in receiving FDA approval, specifies elements, such as restricted product distribution, required vision testing and mandatory risk-benefit assessments, to manage the risk of vision loss associated with Sabril. Like all other antiepileptic drugs, theREMS also addresses the risk for suicidality associated with the class.

The Sabril REMS is administered through Lundbeck’s SHARE (Support, Help and Resources for Epilepsy) program, a comprehensive patient and physician support program designed to provide tools and resources for all of Lundbeck’s epilepsy products, including Sabril. Through SHARE and the recently established SHARE Call Center, patients, caregivers and physicians will have access to information and tools to help manage severe and uncontrolled epilepsy, programs to help facilitate initial and ongoing use of Sabril and support from a team dedicated to helping people fully understand and navigate the Sabril prescribing process.

Sabril causes permanent vision loss in infants, children and adults. Sabril-induced vision loss includes progressive and permanent bilateral concentric visual field constriction in 30 percent or more of patients on the therapy that ranges in severity from mild to severe, including tunnel vision to within 10 degrees of visual fixation, and can result in disability. There are also some reports that Sabril can damage the central retina and decrease visual acuity. The onset is unpredictable and can occur within weeks of starting treatment, or sooner, or at anytime during treatment even after months or years.

Lundbeck



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