Eisai’s epilepsy drug Fycompa to launch in USA

The US subsidiary of Japanese pharma major Eisai’s (TYO: 4523) that its epilepsy drug Fycompa (perampanel) will be available to eligible patients by prescription in the USA beginning January 6, something of a delay given that the drug was approved by the Food and Drug Administration in October 2012.

Fycompa is an adjunctive therapy for the treatment of partial-onset seizures with or without secondarily generalized seizures in patients with epilepsy age 12 years and older. The drug is the first non-competitive AMPA glutamate receptor antagonist to be approved by the FDA, the company noted.

Fycompa has been designated by the US Drug Enforcement Administration as a federally controlled substance (CIII). The supply source from Eisai’s UK production facility was cleared by the FDA last fall (The Pharma Letter September 11, 2013). Fycompa has also been approved in the European Union, Canada, Switzerland and Israel.