Sabril Now Available In US

Lundbeck, a wholly owned subsidiary of H Lundbeck in Denmark, has announced that Sabril (vigabatrin) tablets and powder for Oral Solution are now available for prescribing in the US.

Earlier in August 2009, Sabril was approved by the FDA 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.

Jeffrey Aronin, CEO of Lundbeck, said: “While Sabril is not for everyone confronting these challenging epilepsies, we are so pleased to be able to make this therapy available in the US for the patients who need it.

“The tireless work of our employees, the epilepsy community and the FDA made this day possible. Above all, we are gratified to be able to bring an important new treatment option to patients who can benefit from having approved alternatives to consider.”

Because of the risk of permanent vision loss, Sabril is available 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 program called SHARE (Support Help and Resources for Epilepsy), required vision testing, a patient registry, and mandatory benefit-risk assessments.

The Sabril REMS is administered through Lundbeck’s special restricted distribution program called SHARE, a comprehensive patient and physician support program designed to provide tools and resources for all of Lundbeck’s epilepsy products, including Sabril.