The CHMP positive opinion was supported by a Phase III international, double-blind, randomized, active-controlled, non-inferiority trial, conducted according to guidance issued by the EMA and the International League Against Epilepsy, results of which were previously presented at the European Academy of Neurology and European Congress on Epileptology meetings earlier this year.2,3,4,5 Results from the study are expected to be published during November 2016 within The Lancet Neurology.
“Choosing the first antiepileptic drug (AED) is of utmost importance for patients with newly diagnosed disease – since they will most likely need long-term therapy, the AED must be effective, well-tolerated, have low potential for drug–drug interactions, and suit their disease and lifestyle profiles”, explained Professor Michel Baulac, Hôpital de la Pitié-Salpêtrière, Paris, France. “When we try to select an existing monotherapy option for patients based on their profile and the attributes of the AED, we are left with few choices. Consequently, adoption of a positive opinion by CHMP, recommending approval of lacosamide as monotherapy, represents a major advance in terms of new options for people with epilepsy and of possibilities to tailor treatment to the individual patient.”
The lifetime prevalence of epilepsy is 2-5% and seizure incidence rates tend to be higher in people over the age of 65.6 An estimated seven million people in Europe will have an epileptic seizure at some time during their lives, and as many as 30% may have a treatment-refractory form of the condition. This CHMP positive opinion takes us one step closer to VIMPAT® being approved as monotherapy for patients with partial-onset seizures and, pending approval, could provide an additional treatment option for this patient population, representing a significant unmet need7.
“Epilepsy can affect people in many different ways, and a range of treatment options are required to ensure that therapy is tailored to a person’s individual needs. UCB is committed to making VIMPAT® available to help more people living with epilepsy worldwide,” explained Jeff Wren, Head of UCB’s Neurology Patient Value Unit. “The CHMP’s positive opinion builds on our longstanding commitment to help people with seizure disorders at every point of their journey.”
Currently VIMPAT® is approved in 44 countries as adjunctive therapy for the treatment of partial-onset seizures in adults with epilepsy (ages ≥ 17 years in the U.S., ages ≥ 16 years in the EU9), and is already licenced as monotherapy in the US (ages ≥ 17 years8). VIMPAT® peak sale expectations are confirmed to reach at least €1.2 billion by 2020.