Eisai Announces FDA Approval of BANZEL (rufinamide) for Adjunctive Treatment of Seizures Associated with Lennox-Gastaut Syndrome in Pediatric Patients Ages 1-4

WOODCLIFF LAKE, N.J., Feb. 13, 2015 /PRNewswire/ -- Eisai Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for BANZEL® (rufinamide) as an adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome (LGS) in pediatric patients from one to four years of age. BANZEL was first approved by the FDA in November 2008, for the adjunctive treatment of seizures associated with LGS in children ages four years and older and adults.

"The approval of BANZEL for pediatric patients, one to four years of age, represents an important milestone, as it may help to address an unmet need of younger patients with Lennox-Gastaut Syndrome," said Lynn Kramer, Chief Clinical Officer (ECL) and President, Neuroscience & General Medicine, PCU Eisai Product Creation Systems, Eisai Inc. "At Eisai, we are committed to our corporate human health care (hhc) mission and are proud to help serve patients and families living with this rare condition."

The approval of BANZEL as adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome (LGS) in pediatric patients from 1 to 4 years of age is based on a pharmacokinetic bridging study of a Phase III clinical trial (study 303) which demonstrated the pharmacokinetic and safety profiles are consistent with those seen in ages 4 and above.

In this study, comparing BANZEL (45 mg/kg per day) adjunctive treatment (n=25) to the adjunctive treatment with an AED of the investigator's choice (n=11) in pediatric patients (1 year to less than 4 years of age) with inadequately controlled Lennox-Gastaut Syndrome, the adverse reaction profile was generally similar to that observed in adults and pediatric patients 4 years of age and older treated with BANZEL. Adverse reactions that occurred in at least 2 (8%) BANZEL-treated patients and with a higher frequency than in the AED comparator group were: vomiting (24%), somnolence (16%), bronchitis (12%), constipation (12%), cough (12%), decreased appetite (12%), rash (12%), otitis media (8%), pneumonia (8%), decreased weight (8%), gastroenteritis (8%), nasal congestion (8%), and pneumonia aspiration (8%).

BANZEL Important Safety Information

Contraindication:

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 the pooled, double-blind, adjunctive therapy studies in adults and pediatric patients ages 4 and older, 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%).

In a multicenter, parallel group, open-label study in pediatric patients (1 year to less than 4 years of age) the most commonly observed (≥10%) adverse reactions and with a higher frequency with BANZEL vs any other AED, respectively, were vomiting (24% vs 9%), somnolence (16% vs 0%), constipation (12% vs 9%), cough (12% vs 9%), bronchitis (12% vs 0%), rash (12% vs 9%), and decreased appetite (12% vs 9%).

Please see the BANZEL Full Prescribing Information

About BANZEL®(rufinamide)

BANZEL® (rufinamide) is an anti-epileptic drug indicated for adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in children 1 year 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 1 year 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.

SOURCE Eisai Inc.

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