Eisai Announces FDA Approval of Fycompa in Pediatric Patients as Young as 4 Years Old for the Treatment of Partial-Onset Seizures
WOODCLIFF LAKE, N.J., Sept. 28, 2018 /PRNewswire/ — 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.
“Taking an AED as prescribed every day is a critical part of reaching the goal of seizure freedom for pediatric patients,” said Jesus Eric Piña-Garza, MD, pediatric neurologist, Tri-Star Medical Group Children’s Specialists. “With Fycompa, children and their parents now have a once-daily dosing option with a long half-life that can fit into their increasingly busy lives.”
Some patients may also experience breakthrough seizures, which occur in individuals who have previously achieved reliable seizure control. Breakthrough seizures can be caused by any number of factors including illness and loss of sleep. Missed medication doses are the number one cause of breakthrough seizures. Fycompa has a long half-life and in a pharmacokinetic study, it has been demonstrated that in the event of a missed dose, plasma levels remain relatively stable.
The use of Fycompa for the treatment of partial-onset seizures in adolescents and children 4 to <12 years with epilepsy is supported by efficacy extrapolated from three Phase 3 adequate and well-controlled studies of Fycompa in adult patients with POS. Safety was evaluated in two studies in pediatric patients 4 to <12 years of age with epilepsy, a total of 225 patients received Fycompa, with 110 patients exposed for at least 6 months, and 21 patients for at least 1 year. Adverse reactions in pediatric patients 4 to <12 years of age were similar to those seen in patients 12 years of age and older.
Final results of these studies supporting the FDA approval in pediatric patients 4 years and older will be presented at an upcoming medical meeting.
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 12 years of age and older, and then as monotherapy for POS with or without secondarily generalized seizures in patients with epilepsy 12 years of age and older. To date, Fycompa is approved in 55 countries and has treated more than 200,000 patients worldwide across all indications.
Epilepsy is a medical condition that produces seizures affecting a variety of mental and physical functions. Epilepsy is one of the most common neurological disorders, which affects about 3.4 million people in the United States, including 470,000 children. Children with uncontrolled seizures are at greater risk for sudden unexpected death in epilepsy (SUDEP), which is relatively uncommon in childhood, but the risk increases if epilepsy persists into adulthood.
Partial-onset seizures are the most common type of seizure seen in people with epilepsy, accounting for 60 percent of all seizures. Convulsive seizures account for up to 25 percent of all epilepsy, with primary generalized tonic-clonic seizures being one of the most common and severe forms of seizures.
Missed medication doses are the number one cause of breakthrough seizures, which can cause significant injury to patients. People who experience breakthrough seizures have an increased risk of fractures or head injuries, emergency room (ER) visits, and hospitalization, as well as an associated increase in healthcare costs.
Fycompa is a prescription medicine used in people with epilepsy aged 4 and older alone or with other medicines to treat partial-onset seizures with or without secondarily generalized seizures, and with other medicines to treat primary generalized tonic-clonic seizures for people with epilepsy aged 12 and older.
Fycompa, a unique oral medication, is a selective, non-competitive AMPA (alpha-amino-3-hydroxy-5- methyl-4-isoxazolepropionic acid) receptor antagonist. The precise mechanism by which Fycompa exerts its antiepileptic effects in humans is unknown. In a pharmacokinetic study, it has been demonstrated that because of its long half-life, a missed dose of Fycompa does not significantly impact plasma levels.
Fycompa is supplied as 2 mg, 4 mg, 6 mg, 8 mg, 10 mg and 12 mg film-coated tablets, and as a 0.5 mg/mL oral suspension formulation. Fycompa has been designated by the U.S. Drug Enforcement Administration as a federally-controlled substance (CIII).
Please visit www.fycompa.com to learn more about the treatment.
About Eisai Inc.
At Eisai Inc., human health care (hhc) is our goal. We give our first thoughts to patients and their families, and helping to increase the benefits health care provides. As the U.S. pharmaceutical subsidiary of Tokyo-based Eisai Co., Ltd., we have a passionate commitment to patient care that is the driving force behind our efforts to discover and develop innovative therapies to help address unmet medical needs.
Eisai is a fully integrated pharmaceutical business that operates in two global business groups: oncology and neurology (dementia-related diseases and neurodegenerative diseases). Each group functions as an end-to-end global business with discovery, development, and marketing capabilities. Our U.S. headquarters, commercial and clinical development organizations are located in New Jersey; our discovery labs are in Massachusetts and Pennsylvania; and our global demand chain organization resides in Maryland and North Carolina. To learn more about Eisai Inc., please visit us at www.eisai.com/US and follow us on Twitter and LinkedIn.
SOURCE Eisai Inc.
Posted: September 2018
- FDA Approves Additional Use of Antiepileptic Drug Fycompa as Monotherapy for Partial-onset Seizures – July 27, 2017
- Eisai Announces FDA Approval of Fycompa (perampanel) Oral Suspension – May 2, 2016
- FDA Approves Fycompa as Adjunctive Treatment for Primary Generalized Tonic-Clonic Seizures – June 22, 2015
- FDA Approves Fycompa to Treat Seizures – October 22, 2012
- FDA Accepts Resubmission of Perampanel New Drug Application – March 5, 2012
- Eisai Resubmits Perampanel (E2007) NDA to FDA – December 26, 2011
- U.S. FDA Provides Response to Perampanel New Drug Application – July 29, 2011
- Eisai to Submit Marketing Authorization Applications in the U.S. and EU for Perampanel as Adjunctive Therapy for Partial Onset Seizures in Patients with Epilepsy – January 25, 2011
Fycompa (perampanel) FDA Approval History
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