By RTT News, September 01, 2014, 03:48:00 AM EDT
(RTTNews.com) - UCB announced that the U.S. Food and Drug Administration 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 U.S. 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 U.S. monotherapy approval for VIMPAT is based on a Phase 3 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.
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UCB Says FDA Approves SNDA For VIMPAT