WOODCLIFF LAKE, N.J., Aug. 19, 2013 /PRNewswire/ -- Eisai Inc. filed a petition today with the U.S. Court of Appeals for the District of Columbia asking the court to direct the Drug Enforcement Administration (DEA) to promptly schedule the company's epilepsy drug so that it can make it available to patients.
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FYCOMPA (perampanel), a new chemical entity (NCE), was approved by the Food and Drug Administration (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. The FDA sent its scheduling recommendation for FYCOMPA to the DEA in January 2013, but seven months later the DEA has not yet begun the scheduling process.
In its petition for a writ of mandamus, Eisai asserted that the DEA has "unreasonably" and "egregiously" delayed the scheduling of FYCOMPA, a delay which means that thousands of potential patients suffering with partial onset seizures a serious medical condition for which there is great unmet medical need cannot obtain the drug. The papers also challenge the justification for the delay and highlight the lack of any timetable, predictability, or transparency related to the DEA's scheduling process. In addition, it explains 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 the FDA that the drug is safe and effective when prescribed in accordance with its labeling.
Partial onset seizures occur in about 60 percent of those with epilepsy and approximately 30 percent of these patients -- several hundred thousand people in the U.S. -- have seizures that are not controlled.
Attached to the petition are several letters from the epilepsy community urging expedited scheduling of FYCOMPA and other epilepsy drugs.
"People with epilepsy, their caregivers, or parents of children with epilepsy find it very frustrating to wait for an additional treatment option for seizure control due to DEA delay," said Phil Gattone, President and CEO of the Epilepsy Foundation, a leading patient organization representing the 2.2 million Americans with epilepsy and their families. "It is even more disheartening to know that the system is not required to have a clear timeline for consumers."
Michael Rogawski, M.D., Ph.D., a professor of neurology at the University of California, Davis, sent the DEA a personal letter expressing his frustration with the agency's significant delay in scheduling FYCOMPA."There are a large number of patients who could benefit from FYCOMPA if it were available. It is unreasonable to delay access of this medication to patients who could potentially benefit," he said.
"We have reached out to the DEA several times to better understand why there is such a lengthy delay in scheduling this drug and making it available to patients," said Allen Waxman, Senior Vice President and General Counsel of Eisai Inc. "Unfortunately, 10 months after FDA approval, we still await the initiation of the DEA's scheduling process."
FDA requires that sponsors of drugs that FDA recommends for scheduling wait until the scheduling process is finished before commercially distributing the product. The scheduling process for NCEs, such as FYCOMPA, has lengthened over the past fifteen years from an average of 49 days during the 1997 to 1999 timeframe, to an average of 237 days between 2009 and 2013.
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Eisai Takes Legal Action In Federal Court Alleging Unreasonable Delay In DEA Scheduling Of FYCOMPA™ (perampanel)