Eisai Reports FDA OK of Seizure Med in Pediatric Patients as Young as 4

Eisai Inc. announced today that the U.S. Food and Drug Administration (FDA) expanded the indication of its antiepileptic drug FYCOMPA® (perampanel) CIII for monotherapy and adjunctive use in pediatric patients 4 years and older for the treatment of partial-onset seizures (POS) with or without secondarily generalized seizures. The approval includes both FYCOMPA tablet and oral suspension formulations.

“Eisai is working tirelessly to provide treatment options for patients of all ages to help better control seizures and achieve the ultimate goal of seizure freedom,” said Lynn Kramer, MD, Chief Clinical Officer and Chief Medical Officer, Neurology Business Group, Eisai. “We are excited about the potential of FYCOMPA as an important tool to reduce the incidence of seizures among pediatric patients living with epilepsy. This milestone underscores our commitment to providing treatment options for children with epilepsy for whom there is still a significant unmet need.”

Today, an estimated 470,000 children in the U.S. are living with epilepsy. Up to 40 percent will not achieve seizure freedom with existing treatment and will struggle with uncontrolled seizures.

https://www.streetinsider.com/FDA/Eisai+Reports+FDA+Approval+of+FYCOMPA+in+Pediatric+Patients+as+Young+as+4+Years+Old+for+the+Treatment+of+Partial-Onset+Seizures/14655756.html