FDA approves Vimpat monotherapy in Epilepsy-UCB

UCB announced that the FDA has approved a supplemental new drug application (sNDA) for Vimpat(lacosamide) C-V as monotherapy in the treatment of partial-onset seizures in patients with Epilepsy aged 17 years and older. This is a new indication for Vimpat which is already approved in the US as adjunctive treatment for partial-onset seizures in patients in this age group. This new indication means that adults with partial-onset seizures can be initiated on Vimpat monotherapy, and patients already on an anti-epileptic drug can be converted to Vimpat monotherapy. UCB also announced that the FDA has approved a new single loading dose administration option for all formulations of Vimpat, when used as monotherapy or adjunctive therapy in the treatment of partial-onset seizures in patients with epilepsy aged 17 years and older.

The new monotherapy approval is based on a Phase III historical-control conversion to lacosamide monotherapy study in adult Epilepsy patients with partial-onset seizures. The study met its primary endpoint, demonstrating that the exit percentage, defined as the estimated percentage of patients meeting pre-defined exit criteria, for patients converting to lacosamide 400 mg/day was significantly lower than the historical control exit percentage, used as a comparator. Lacosamide 300 mg/day also met the pre-specified criteria for efficacy.