UCB plots new Vimpat submissions after positive monotherapy results
pharmafile | October 8, 2015 | News story | Research and Development | EMA, European Medicines Agency, UCB, carbamazepine, epilepsy, lacosamide, phase III, vimpat
A Phase III non-inferiority study comparing UCB’s Vimpat with carbamazepine suggests the two drugs can be used as monotherapy treatments.
The study compared Vimpat (lacosamide) and carbamazepine-controlled releases, as monotherapies in 888 European patients aged 16 years and older with newly or recently-diagnosed epilepsy.
The study met its primary endpoint for the proportion of patients remaining seizure free for six consecutive months of treatment, in newly or recently-diagnosed adult patients with partial-onset seizures.
Professor Dr Iris Loew-Friedrich, chief medical officer and executive vice president of UCB says: “We are very pleased with these top-line results which reported 90% of lacosamide patients remaining seizure free for six consecutive months, demonstrating non-inferiority of lacosamide. These encouraging data support lacosamide as monotherapy for partial onset seizures, which is already approved and launched in the United States and should soon reach patients in the EU.”
Jeff Wren, patient value head neurology and executive vice president of UCB says: “In recent years Vimpat has provided value for patients requiring add-on therapy for their focal epilepsy. This study suggests that it may provide similar benefits as a first-line monotherapy, building on our commitment on enhancing value for those with seizure disorders at every point in their epilepsy journey.”
Vimpat is approved as an adjunctive therapy for the treatment of partial-onset seizures in adults with epilepsy aged between 17 years in the US and 16 years in the EU. However, in the EU, Lacosamide is not currently approved for use as monotherapy. Following the trial success, UCB plans a submission to EU regulatory authorities in the first half of 2016.
Currently Vimpat is available in 47 countries and UCB plans to submit their data to the EMA as part of its bid to extend the marketing authorisation of Vimpat as monotherapy.
Yasmita Kumar
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