News

UCB withdraws EU marketing authorisation application for lacosamide

Brussels, BElgium
Sep 25, 2008

UCB is withdrawing European Marketing Authorisation Application with the European Medicines Agency (EMEA) for Vimpat® (lacosamide) in the treatment of diabetic neuropathic pain, as announced. The EMEA's Committee for Medicinal Products for Human Use (CHMP) did not observe the clinical effects of lacosamide diabetic neuropathic pain to be convincing. An additional clinical trial to substantiate the magnitude of effect of lacosamide in diabetic neuropathic pain would be conducted by UCB in consultation with the agency. 

Vimpat® was earlier 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 expected to be launched in the EU from mid-September 2008. Vimpat® is presently under review by the U.S. Food and Drug Administration (FDA) for the same.