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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 2013).

In the U.S., Vimpat is approved as adjunctive therapy for the treatment of partial-onset seizures in patients with epilepsy aged 17 years and older. The Phase III, historical-controlled study to be presented at AES 2013 was conducted to assess the efficacy and safety of conversion to Vimpat monotherapy in adult patients continuing to experience partial-onset seizures while taking one to two other anti-epileptic drugs.

Data to be presented at AES show that the study met its primary endpoint, demonstrating that the predicted exit rate for patients converting to lacosamide 400mg/day (0.300:95% confidence interval [0.246, 0.355]) was significantly lower than the historical control exit rate, used as a comparator (0.653). In the study, a lacosamide 300mg/day arm was added to blind the treatment group and to ensure a study design consistent with the historical control studies. The most common treatment-emergent adverse events reported for lacosamide (300 mg/day and 400 mg/day) were dizziness, nausea and headache. These adverse events were generally similar to those attributed to lacosamide in placebo-controlled adjunctive studies.

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