UCB announced that the U.S. Food and Drug Administration (FDA) has approved Vimpat® (lacosamide), a new antiepileptic drug (AED). Vimpat® is for use as an add-on therapy for the treatment of partial-onset seizures in people with epilepsy who are 17 years and older.
Epilepsy is a chronic neurological disorder affecting approximately three million people in the U.S. Less than half (47%) will attain seizure control with their first AED, and more than 30% will continue to experience seizures despite trying two or more AEDs.
"At UCB, we are thrilled that Vimpat® will be a new option for people with epilepsy in the U.S. living with uncontrolled partial onset seizures. Vimpat® confirms our proven commitment to the epilepsy community," said Roch Doliveux, CEO of UCB. "The approval of Vimpat® in the U.S. demonstrates that we are continuing to deliver on our strategy to provide innovative medicine for patients who suffer from severe diseases."
Preclinical studies indicate that Vimpat® has a novel mechanism of action. The precise mechanism by which Vimpat® exerts its antiepileptic effect in humans remains to be fully elucidated. In preclinical studies, Vimpat®'s mechanism of action has been shown to involve the modulation of sodium channel activity in the nervous system. Sodium channels play a crucial role in regulating the activity of the nervous system to help nerve cells communicate. Sometimes sodium channels become abnormally overactive and nerve cells become too excited, which may produce a seizure.
Vimpat®'s mechanism of action is thought to reduce this sodium channel over-activity by prolonging the longer lasting resting state of the channel, a different action compared with current sodium channel blocking drugs. This action then regulates the activity of over-excited nerve cells, which may contribute to the control of seizures.
In preclinical studies, Vimpat® has also been shown to bind to the collapsin response mediator protein-2 (CRMP-2), an important target that affects the way that nerves differentiate and grow. The precise nature of the interaction between Vimpat® and CRMP-2 and between CRMP-2 and seizure control is not known.
Vimpat® demonstrated efficacy and tolerability when combined with a broad range of existing AEDs. Patients began experiencing a reduction in seizures during the titration phase and maintained or improved seizure control throughout the studies. The most common adverse events ( > 10 percent and greater than placebo) reported in these trials included diplopia, headache, dizziness and nausea. More than half of the patients completing the clinical trials opted to continue treatment, some for as long as five years.