FDA Approves Fycompa for Use as Monotherapy in Some Epilepsy Cases

Eisai is first to take advantage of new FDA regulatory pathway

The FDA has approved perampanel CIII (Fycompa, Eisai Inc.) as monotherapy for the treatment of partial-onset seizures (POS) with or without secondarily generalized seizures in patients with epilepsy 12 years of age and older. The medication was previously approved for adjunctive use for POS and primary generalized tonic-clonic seizures in epilepsy patients in that age group.

Fycompa became the first antiepileptic drug approved by the FDA following a new pathway outlined by the agency in 2016. The FDA advised companies with approved antiepilepsy drugs that "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.

"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," 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.

Fycompa was initially approved for adjunctive use in POS in 2012. To date, more than 100,000 patients have been treated with the medication. 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.

Source: Eisai Inc.; July 26, 2017.