UCB has taken this decision based on the European Medicines Agency’s (EMEA) Committee for Medicinal Products for Human Use (CHMP) view that the magnitude of the clinical effect of lacosamide in diabetic neuropathic pain has not been convincingly established.
Following thorough consultation with the agency, UCB would need to initiate an additional clinical trial to further substantiate the magnitude of effect of lacosamide in diabetic neuropathic pain.
Previuosly, Vimpat was approved by the European Commission for the adjunctive treatment of partial-onset seizures with or without secondary generalization in patients with epilepsy, aged 16 years and over. The product is being launched in the EU from mid-September 2008.
Vimpat is currently under active review by the FDA for the adjunctive treatment of partial-onset seizures in patients with epilepsy, aged 16 years and over.