FDA approves Eisai’s FYCOMPA® (perampanel) for use as monotherapy for the treatment of partial-onset seizures.
The U.S. Food and Drug Administration (FDA) has approved Eisai Inc.’s supplemental New Drug Application (sNDA) for FYCOMPA®(perampanel) CIII as monotherapy use for the treatment of partial-onset seizures (POS) with or without secondarily generalized seizures in patients with epilepsy 12 years of age and older. In addition to the new monotherapy use in POS, FYCOMPA is approved for adjunctive use for POS and primary generalized tonic-clonic seizures (PGTC) in patients with epilepsy 12 years of age and older.
FYCOMPA is the first AED approved by the FDA following the pathway outlined in the agency’s September 13, 2016 General Advice Letter to AED NDA holders stating “it is acceptable to extrapolate the efficacy and safety of drugs approved as adjunctive therapy for the treatment of partial onset seizures (POS) to their use as monotherapy for the treatment of POS.” FYCOMPA’s approval for monotherapy use has been extrapolated based on comparable exposures to those obtained with adjunctive use in clinical trials for the treatment of partial-onset seizures.
“This approval is good news for the epilepsy community because it means that more physicians and patients will have access to a single agent option for partial-onset seizures,” said Jacqueline A. French, MD, Professor of Neurology in the Epilepsy division at NYU Langone Medical Center, Chief Scientific Officer for the Epilepsy Foundation and Director of the Epilepsy Study Consortium, a nonprofit organization devoted to speeding new therapies through the development process and into the clinic. “To date, conducting clinical trials with single agents in epilepsy has been problematic. Now, with this change in the regulatory pathway, we have a safe and efficient process for quicker access to single agent therapies for partial-onset seizures.”
“Approximately one-third of people living with epilepsy have seizures that are not adequately controlled,” said Robert Wechsler, MD, PhD, Medical Director, Idaho Comprehensive Epilepsy Center. “Having a new monotherapy option for partial-onset seizures that is once-a-day gives physicians and patients an effective treatment option that has the potential to make a difference in patients’ lives.”
FYCOMPA was initially approved for adjunctive use in POS in 2012 and has been approved in 55 countries worldwide. To date, more than 100,000 patients have been treated with FYCOMPA. An oral suspension formulation was also approved in 2016. In the three initial adjunctive pivotal clinical trials in patients with partial-onset seizures, results showed improvement in seizure control in patients taking FYCOMPA compared with those taking placebo.
“We are proud to be the first company to receive an approval for monotherapy use in partial-onset seizures following the FDA regulatory pathway of extrapolation that was based on the agency’s careful review of existing data generated in monotherapy and adjunctive therapy trials,” said Lynn Kramer, MD, Chief Clinical Officer and Chief Medical Officer, Neurology Business Group, Eisai. “This effort is consistent with Eisai’s broader mission of addressing the unmet needs of patients and making sure our therapies are available to those who need them in a timely manner.”
(Source: PR Newswire)
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