US FDA approves Eisai’s epilepsy drug, Fycompa
The US Food and Drug Administration (FDA) has approved Japanese drugmaker Eisai’s antiepileptic drug, Fycompa, for use in the United States. This follows the European Commission’s approval of the drug for use in Europe, back in September.
Fycompa (perampanel) tablets have been approved to treat partial onset seizures in patients with epilepsy aged 12 years and older. Partial seizures are the most common type of seizure seen in people with epilepsy.
The FDA’s approval was based on three clinical trials of Fycompa, which showed improvement in seizure control in patients taking the drug compared to those on placebo.
“Some people with epilepsy do not achieve satisfactory seizure control from treatments they are currently using. It is important to have a variety of treatment options available for patients with epilepsy.”
Russell Katz, M.D., director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research.
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