FDA backs added use for UCB's Vimpat

Belgium’s largest drugmaker UCB (Euronext Brussels: UCB) said today that the US 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 USA and Europe as adjunctive treatment for partial-onset seizures. 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. For the first half of 2014 Vimpat saw revenues increase 17% to 217 million euros ($286 million), below the market expectation of 229 million euros (The Pharma Letter July 31).

New single loading dose also approved

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.1

“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 USA 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 Iris Loew Friedrich, chief medical officer and executive vice president, UCB.