FDA approves Vimpat C-V as monotherapy in the treatment of partial-onset seizures

BRUSSELS, Belgium — UCB on Monday announced that the Food and Drug Administration has approved a supplemental new drug application for Vimpat (lacosamide) C-V as monotherapy in the treatment of partial-onset seizures in patients with epilepsy ages 17 years and older.

 

This is a new indication for Vimpat, which is already approved in the United States as an 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 ages 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," stated Iris Loew Friedrich, UCB chief medical officer and EVP. "Now, physicians and epilepsy patients in the United States 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.”