Trials & Filings

UCB Files SNDA for Vilpat

Seeks approval as epilepsy monotherapy

By: Gil Roth

President, Pharma & Biopharma Outsourcing Association

UCB‘s sNDA for Vimpat (lacosamide) has been accepted by the FDA. The sNDA covers the drug as a monotherapy in the treatment of partial-onset seizures in patients with epilepsy aged 17 years and older. Investigational data from UCB’s Phase III Vimpat conversion to monotherapy study in adults with partial-onset seizures that support the U.S. filing will be presented by leading clinical researchers at the Annual Meeting of the American Epilepsy Society in Washington DC (6-10 December 20...

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