UCB announced that it is withdrawing the European Marketing Authorisation Application with the European Medicines Agency (EMEA) for Vimpat (lacosamide) in the treatment of diabetic neuropathic pain.

UCB has taken this decision based on the EMEA's 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.

Vimpat was approved by the European Commission for the adjunctive treatment of partial-onset seizures with or without secondary generalisation in patients with epilepsy, aged 16 years and over, at the end of August. The product is being launched in the EU from mid-September 2008.

Vimpat is currently under active review by the US Food and Drug Administration (FDA) for the adjunctive treatment of partial-onset seizures in patients with epilepsy, aged 16 years and over.

At the end of July, UCB announced that it had received an action letter (not-approvable letter) from the U.S. FDA for lacosamide for the treatment of diabetic neuropathic pain in adults.

Diabetic neuropathic pain is a painful and potentially debilitating complication of diabetes often characterized by a stabbing or burning sensation in the legs, feet and/or hands.

UCB is a global leader in the biopharmaceutical industry dedicated to the research, development and commercialisation of innovative medicines with a focus on the fields of central nervous system and immunology disorders.