UCB Wins FDA Approval for Seizure Drug
UCB, a biopharmaceutical and specialty chemical company, has announced that the FDA has approved Vimpat, a new antiepileptic drug for use as an add-on therapy for the treatment of partial-onset seizures in people with epilepsy who are 17 years and older.
The approval of Vimpat is based on efficacy and safety data from one Phase II and two Phase III clinical trials with approximately 1,300 people with epilepsy age 16 and older who had uncontrolled partial-onset seizures.
Vimpat will be available as oral tablets and as an intravenous (IV) infusion to allow for consistent treatment in a hospital setting. The IV formulation of Vimpat does not require dilution prior to administration.
Vimpat oral solution is still under review by the FDA. As with many other neurology products, Vimpat will be designated as a controlled substance. The recommended classification is still under review by authorities, however this is expected to be finalized in early 2009 at which time Vimpat will be available in US pharmacies.
Roch Doliveux, CEO of UCB, said: “Vimpat confirms our proven commitment to the epilepsy community. The approval of Vimpat in the US demonstrates that we are continuing to deliver on our strategy to provide innovative medicine for patients who suffer from severe diseases.”