H. Lundbeck A/S Release: Five-Year Data From SABRIL® (Vigabatrin) Registry Presented At American Epilepsy Society Annual Meeting

SEATTLE--(BUSINESS WIRE)--A late-breaking poster presentation focused on five-year vision data from Lundbeck’s SABRIL (vigabatrin) patient registry was presented at the annual meeting of the American Epilepsy Society (AES). The data set includes 6,823 patients enrolled from August 21, 2009 through August 26, 2014.1 The U.S. Food and Drug Administration (FDA) requires a Risk Evaluation and Mitigation Strategy (REMS) due to the risk of SABRIL-induced permanent vision loss, including an ongoing patient registry.

SABRIL is indicated as adjunctive therapy for patients 10 years of age and older 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. SABRIL is not indicated as a first line agent for CPS.2 SABRIL is indicated as monotherapy for pediatric patients 1 month to 2 years of age with infantile spasms (IS) for whom the potential benefits outweigh the potential risk of vision loss.2

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