UCB announced that it received a not-approvable letter from US Food and Drug Administration (FDA) for lacosamide for the treatment of diabetic neuropathic pain in adults.
The company will seek clarification from the FDA of its position and of the additional information required to obtain final marketing approval.
UCB confirmed that lacosamide (Vimpat) is also currently under active review by the FDA for the adjunctive treatment of partial onset seizures in patients with epilepsy at the age of 16 and more.
In June 2008, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) issued a positive opinion recommending that the European Commission grant a marketing authorization for Vimpat (lacosamide) for the adjunctive treatment of partial onset seizures with or without secondary generalization in patients with epilepsy at the age of 16 and more. Vimpatis is also under review by the EMEA for the treatment of diabetic neuropathic pain in adults.
Vimpat is an investigational therapy for the reduction of pain and discomfort in patients with diabetic neuropathic pain - a common and painful complication of diabetes.
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.