UCB receives FDA not-approvable letter for diabetes drug

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, age 16 and over. Vimpat is also under review by the European Medicines Agency 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.

Vimpat is said to be the first agent of its kind to be clinically studied for the treatment of diabetic neuropathic pain. Preclinical studies indicate that Vimpat has a novel, dual mode of action.