BETHESDA, MD 21 August 2009—FDA and Lundbeck Inc. today announced the approval of vigabatrin, or Sabril, for the treatment of infantile spasms and as add-on therapy for the treatment of complex partial seizures in adults.
The agency said the oral antiepileptic drug is the first U.S.-approved medication for the treatment of infantile spasms, which are difficult to control.
Permanent vision damage, ranging from mild to severe, has occurred in both eyes of at least 30% of patients exposed to vigabatrin, the company said. Patients of all ages and at any time during therapy have been affected.
FDA said the product`s labeling will have a boxed warning alerting health care professionals to the possibility that vigabatrin users may lose peripheral vision and have difficulty visually differentiating between objects.
Because of the risk of permanent vision damage, FDA said, vigabatrin will be available only through a restricted distribution program, which Lundbeck has named Support Help and Resources for Epilepsy, or SHARE.
The company said the restricted distribution program is part of the agency-mandated risk evaluation and mitigation strategy (REMS), "a critical component in receiving FDA approval" of vigabatrin. Also part of the REMS for managing the drug-related risk of permanent vision loss are required periodic vision tests and mandatory benefit–risk assessments.
Official labeling for the drug is not yet available online.
The company said the most commonly observed adverse reactions in adults receiving vigabatrin 3 g/day, the recommended dosage, were dizziness, fatigue, drowsiness, tremor, blurred vision, and arthralgia. In infants, the most common adverse events were drowsiness, bronchitis, and ear infection.
Sabril will be available as an oral solution and tablets.
Lundbeck said it plans to launch the product in the third quarter.
