Eisai has filed a petition with the US Court of Appeals for the District of Columbia asking the court to direct the Drug Enforcement Agency (DEA) to schedule the company's anti-epilepsy drug.
Fycompa (perampanel), a new chemical entity, approved by FDA in October 2012 as an adjunctive therapy for the treatment of partial onset seizures with or without secondarily generalized seizures in patients with epilepsy age 12 and older. FDA sent its scheduling recommendation for Fycompa to the DEA in January 2013, but the DEA has not yet begun the scheduling process, according to Eisai.
In its petition for a writ of mandamus, Eisai asserted that the DEA has "unreasonably" and "egregiously" delayed the scheduling of Fycompa. The petition also challenges the justification for the delay and highlights the lack of a timetable, predictability, or transparency related to the DEA's scheduling process. In addition, Eisai asserts that the DEA's delay also continues to harm Eisai by preventing it from launching Fycompa in the United States even though Eisai demonstrated to the satisfaction of FDA that the drug is safe and effective when prescribed in accordance with its labeling.
FDA requires that sponsors of drugs that FDA recommends for scheduling wait until the scheduling process is finished before commercially distributing the product.