UCB announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) has issued a positive opinion recommending that the European Commission grants a marketing authorisation for lacosamide, proposed trade name Vimpat, for the adjunctive treatment of partial onset seizures with or without secondary generalisation in patients with epilepsy, aged 16 years and older.
The recommendation has been granted for the oral tablet, oral syrup and intravenous formulations.
"The European positive opinion for approval of Vimpat marks a major achievement for patients with epilepsy whose seizures are not well controlled by current antiepileptic drugs, and for UCB, strengthening our leadership in treatments for this severe disease," said Roch Doliveux, CEO, UCB. "Today also represents another significant step forward for UCB in our strategic execution with another innovative medicine to be approved."
The CHMP decision is supported by data from three multi-centre, double blind, placebo controlled clinical trials that evaluated the efficacy, safety and tolerability of lacosamide (200, 400 and 600 mg/day given in two divided doses) in a total of over 1,300 adults with uncontrolled partial onset seizures. Patients in these trials were taking at least one to three antiepileptic drugs (AEDs) and many of the patients had previously tried at least seven AEDs. Across these studies significantly greater than 50% responder rates and reductions in median seizure frequency were seen versus placebo.
Lacosamide was also generally well tolerated with the most common adverse events of lacosamide (?10% and greater than placebo) reported in these trials including dizziness, nausea, diplopia and headache.
"With as many as 30 per cent of epilepsy patients continuing to have seizures despite treatment with antiepileptic drugs, there is a need for new, efficacious and well tolerated treatment options," said Professor Elinor Ben-Menachem, Department of Clinical Neuroscience, Goteborg University, Sweden. "These clinical studies suggest that adjunctive lacosamide may be a useful pharmacological treatment option for patients with partial onset seizures."
Regulatory filings for Vimpat oral tablet, oral solution and intravenous formulation are currently also under review by the US Food and Drug Administration (FDA) for use as adjunctive therapy in the treatment of partial onset seizures in adults with epilepsy. Vimpat, oral tablet, is currently under review by the EMEA and the US FDA for the treatment of diabetic neuropathic pain.