Eisai gets FDA nod for expanded indication of Fycompa
Eisai has received the Food and Drug Administration's clearance for an expanded indication of its antiepileptic drug Fycompa (perampanel) CIII for monotherapy and adjunctive use in pediatric patients age 4 years old and older for the treatment of partial-onset seizures 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," Eisai chief clinical officer and chief medical officer of neurology business group Lynn Kramer said in a statement. "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."
Epilepsy is a medical condition that produces seizures affecting a variety of mental and physical functions. An estimated 470,000 children in the United States are living with epilepsy. Up to 40% will not achieve seizure freedom with existing treatment and will struggle with uncontrolled seizures, according to the company.
Fycompa was initially approved for adjunctive use in POS in 2012 and was later approved as adjunctive therapy for PGTC seizures in patients with epilepsy age 12 years old and older, and then as monotherapy for POS with or without secondarily generalized seizures in patients with epilepsy age 12 years old and older.
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," Eisai chief clinical officer and chief medical officer of neurology business group Lynn Kramer said in a statement. "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."
Epilepsy is a medical condition that produces seizures affecting a variety of mental and physical functions. An estimated 470,000 children in the United States are living with epilepsy. Up to 40% will not achieve seizure freedom with existing treatment and will struggle with uncontrolled seizures, according to the company.
Fycompa was initially approved for adjunctive use in POS in 2012 and was later approved as adjunctive therapy for PGTC seizures in patients with epilepsy age 12 years old and older, and then as monotherapy for POS with or without secondarily generalized seizures in patients with epilepsy age 12 years old and older.