New indication for VIMPAT (lacosamide): UCB's anti-epileptic drug approved by FDA as monotherapy in the treatment of patients with partial-onset seizures
Brussels (Belgium), 1st September, 2014 – 0700 (CEST) – regulated information – UCB announced today that the U.S. Food and Drug Administration (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 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 today 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.
“People living with epilepsy have individual needs. It’s our aim at UCB to provide as many patients as possible with various options to reduce their seizures. Now, physicians and epilepsy patients in the U.S. have more VIMPAT® options to treat partial-onset seizures – VIMPAT® as an initial monotherapy, converting to VIMPAT® monotherapy and VIMPAT® as an adjunctive therapy. In addition, based on individual patients’ needs, physicians can choose between VIMPAT® formulations - tablets, oral solution or injection. Also, initiation of VIMPAT® as a single loading dose provides physicians with an alternative administration option to the standard titration schedule,” said Professor Dr. Iris Loew Friedrich, Chief Medical Officer and Executive Vice President, UCB.
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