FDA Grants Eisai's sNDA for Rufinamide Priority Review as Adjunctive Treatment in Pediatric Patients Ages 1-4 for Seizures Associated with Lennox-Gastaut Syndrome

WOODCLIFF LAKE, N.J., Oct. 14, 2014 /PRNewswire/ -- Eisai Inc. announced today that the U.S. Food and Drug Administration (FDA) has accepted the company's sNDA for rufinamide and granted it priority review designation as an adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome (LGS) in pediatric patients from 1 to 4 years of age. BANZEL® (rufinamide) is indicated for the adjunctive treatment of seizures associated with LGS in children 4 years and older and adults. 

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Priority Review designation was assigned to this sNDA because FDA requested this pediatric data under the Best Pharmaceuticals for Children Act.

"LGS is a difficult disease to treat and can have devastating effects on families. At Eisai, we seek to make further contributions to help address the diversified needs of epilepsy patients and their families as part of our corporate human health care (hhc) mission," said Lynn Kramer, Chief Clinical Officer, President, Neuroscience & General Medicine, PCU Eisai Product Creation Systems, Eisai Inc.

About Lennox-Gastaut Syndrome (LGS)
Epilepsy is a disease of the brain characterized by unprovoked seizures that can affect a variety of mental and physical functions. Lennox-Gastaut Syndrome (LGS) is a type of epilepsy that usually appears before the age of 7 and accounts for up to four percent of all childhood epilepsy cases.

BANZEL Indication and Important Safety Information
Indication
BANZEL® (rufinamide) is indicated for adjunctive treatment of seizures associated with Lennox-Gastaut syndrome in children 4 years and older and adults.

Important Safety Information
Contraindications:

  • BANZEL is contraindicated in patients with Familial Short QT syndrome.

Warnings:

  • AEDs increase the risk of suicidal thoughts or behavior in patients. Patients, their caregivers, and families should be informed of the risk and advised to monitor and report any emergence or worsening of depression, suicidal thoughts or behavior, or any unusual changes in mood or behavior, or thoughts of self-harm. If these symptoms occur, consider if it may be related to the AED or illness because epilepsy itself can increase these risks.

  • Use of BANZEL has been associated with central nervous system–related adverse reactions, such as somnolence or fatigue, coordination abnormalities, dizziness, gait disturbances, and ataxia.

Precautions:

  • Formal cardiac ECG studies demonstrated shortening of the QT interval (mean = 20 msec, for doses ≥ 2400 mg twice daily) with BANZEL. Caution should be used when administering BANZEL with other drugs that shorten the QT interval.

  • Multi-organ hypersensitivity syndrome has been reported in association with BANZEL therapy. In clinical trials, hypersensitivity reactions occurred in children less than 12 years of age and within 4 weeks of starting BANZEL therapy. In addition, rare cases of Drug Reaction with Eosinophilia and Systemic Symptoms and Stevens-Johnson syndrome have been reported in association with rufinamide therapy post marketing. If any of these reactions are suspected, BANZEL should be discontinued and alternative treatment started. All patients who develop a rash while taking BANZEL must be closely supervised.

  • As with all AEDs, BANZEL should be gradually withdrawn to minimize the risk of increased seizure frequency.

Adverse reactions:

  • In all patients with epilepsy treated in double-blind, adjunctive therapy studies, the most commonly observed (≥10%) adverse reactions with BANZEL vs placebo, respectively, were headache (25% vs 20%), dizziness (17% vs 10%), fatigue (15% vs 9%), somnolence (13% vs 9%), and nausea (11% vs 7%).

Please see the BANZEL Full Prescribing Information

About BANZEL®
BANZEL® (rufinamide) is an anti-epileptic drug indicated for adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in children 4 years and older and adults. BANZEL® is a triazole derivative that is structurally unrelated to currently marketed antiepileptic drugs (AEDs). The clinical significance of this structural difference has not been established. It is believed to exert its effect by regulating the activity of sodium channels in the brain which carry excessive electrical charges that may cause seizures.

BANZEL®  is currently available in 200 and 400 mg tablets and in a 40 mg/mL oral suspension formula for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in children 4 years and older and adults. It has been on the market since its FDA approval on November 14, 2008.

Eisai Inc.
At Eisai Inc., human health care 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 help address unmet medical needs. We are a fully integrated pharmaceutical business with discovery, clinical, manufacturing and marketing capabilities. Our key areas of commercial focus include oncology and specialty care (Alzheimer's disease, epilepsy and metabolic disorders). To learn more about Eisai Inc., please visit us at www.eisai.com/US

Eisai Inc. has affiliates that are part of a global product creation organization that includes R&D facilities in Massachusetts, New Jersey, North Carolina and Pennsylvania, as well as a global demand chain organization that includes manufacturing facilities in Maryland and North Carolina. Eisai's global areas of R&D focus include neuroscience; oncology; metabolic disorders; vascular, inflammatory and immunological reaction; and antibody-based programs.

Media Inquiries

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Eisai Inc.

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SOURCE Eisai Inc.

Type Press Release

Date Released October 14, 2014

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