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UCB files Vimpat for expanded epilepsy use

Submits monotherapy application to FDA

UCB sign

UCB has filed for US approval of the monotherapy use of its epilepsy drug Vimpat.

The drug has been available since 2008 as an adjunctive, or supplementary, treatment for partial-onset seizures in patients with epilepsy aged 17 or older, but UCB is now pushing for the use of Vimpat (lacosamide) as a primary epilepsy treatment.

Vimpat is already one of UCB's top performers, managing revenues of €294m during the first nine months of 2013, but an expanded indication would push sales up even higher provided it can effectively challenge current treatments, such as GlaxoSmithKline's Lamictal (lamotragine) and Johnson & Johnson's Topamax (topiramate).

Data to support the revised indication comes from a phase III trial involving the conversion of epilepsy patients on adjunct Vimpat treatment to monotherapy with Vimpat through a series of increasing increments.

According to UCB, the study met its primary endpoint demonstrating that the number of patients who discontinued treatment due to an increase in seizure frequency, duration or severity - the exit rate - was significantly lower than the historical control.

One of the study investigators, Dr Robert Wechsler, commented on the trial's capability to support the new indication.

“Results from the study offer important insights and an understanding of the response to lacosamide monotherapy in this patient population,” he said,

Study results are due to be presented at the annual meeting of the American Epilepsy Society in Washington DC this December.

In the EU, Vimpat is also currently available as an adjunctive therapy for people with epilepsy.

However, a non-inferiority monotherapy study is underway to support the potential monotherapy filing with the European Medicines Agency (EMA). Topline results are expected by the end of 2014.

Article by
Thomas Meek

6th November 2013

From: Sales



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