New Hope For Epilepsy Patients
MISSISSAUGA, ON, Sept. 22, 2011 /CNW/ - Eisai Limited, a wholly-owned
Canadian subsidiary of Eisai Inc., announced today the Health Canada
approval and availability of Banzel™ (rufinamide) for the adjunctive treatment of seizures associated with
Lennox-Gastaut syndrome (LGS) in children 4 years of age and older and
adults. One of the most severe forms of childhood epilepsy, LGS is
characterized by frequent seizures and multiple types.
A double-blind, randomized study of LGS patients treated with Banzel as
adjunctive therapy showed a significant reduction in total seizures,
seizure severity and a 42.5 per cent median reduction in the frequency
of drop attacks (tonic-atonic seizures).
Drop attacks are a primary cause of injury in LGS patients.
"Patients living with LGS are in need of treatment options," says Dr.
Jong Rho, Head of Neurology, Alberta Children's Hospital. "Now
available in Canada, Banzel was well tolerated by children with LGS who
were unable to control their seizures with other antiepileptic
medications. The approval of Banzel is great news for Canadians and
provides patients with more options to help control their seizures."
LGS affects between one and four per cent of all Canadian children
diagnosed with epilepsy. The frequent seizures and multiple types
associated with LGS are extremely difficult to control and impact the
quality of life for both patients and their families.
LGS is a disease that is devastating to the lives of patients and
caregivers. Children usually experience the onset of LGS between the
ages of one and five years old; approximately three to seven per cent
of LGS patients die within 10 years. The condition is difficult to
treat, with patients often taking multiple antiepileptic drugs (AEDs)
in attempts to control the seizures. The multiple types and frequency
of seizures can lead to developmental delays, as well as behavioral
"The Canadian approval of Banzel supports the Eisai human health care (hhc) mission to bring medicines to the people who need them the most," says
Takihiro Hirasawa, President, Eisai Canada. "We are pleased to offer
this new treatment option to patients living with LGS in Canada."
Banzel is a triazole derivative that is structurally unrelated to antiepileptic
drugs (AEDs) that are currently available. 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.
"The Canadian epilepsy community welcomes the approval of Banzel,
another important option for those dealing with the multiple and
frequent seizures associated with LGS," says Gail Dempsey, President,
Canadian Epilepsy Alliance.
About Lennox - Gastaut Syndrome (LGS)
One of the most rare and severe forms of epilepsy, LGS usually develops
in preschool-aged children, many of whom have some kind of pre-existing
organic brain disorder such as encephalopathy.
LGS is not only characterized by frequent seizures and multiple types,
it may be accompanied by delayed intellectual development and
personality disorders. The most frequently occurring seizure types
seen in the majority of patients with LGS are tonic (muscle
stiffening), atonic (sudden loss of muscle tone) and absence (staring)
seizures. Tonic-clonic (grand mal), myoclonic (sudden muscle jerks) and
other types of seizures may also occur. Tonic-atonic seizures lead to
the sudden falls seen in LGS patients known as "drop attacks", a
primary cause of injury.
Patients with LGS often have to wear protective helmets with face guards
to protect against head injury from these attacks. Although LGS is most
commonly treated with antiepileptic drugs, patients whose seizures are
difficult to manage with pharmacotherapy may have to undergo surgical
Banzel contains the medicinal ingredient rufinamide, which is an
Banzel is indicated for adjunctive treatment of seizures associated with
Lennox-Gastaut syndrome (LGS) in children 4 years and older and adults.
The Health Canada approval was based on quality, non-clinical, and
clinical evidence submitted. The efficacy of Banzel as adjunctive
treatment for the seizures associated with LGS was established in a
multicentre, double-blind, placebo-controlled, randomized,
parallel-group study. A total of 138 male and female patients (between
4 and 37 years of age) were included if they had a diagnosis of
inadequately controlled seizures associated with LGS (including both
atypical absence seizures and drop attacks) and were being treated with
1 to 3 concomitant stable dose antiepileptic drugs. Compared to
placebo, Banzel-treated patients demonstrated significant improvements
in the number of total seizures, drop attacks, and seizure severity.
Overall, Banzel was generally well-tolerated.
Results of the primary efficacy variable analyses were as follows:
BANZEL-treated patients had a 32.7% median reduction and placebo-treated
patients had an 11.7% median reduction in total seizure frequency per
28 days in the double-blind phase relative to the baseline phase
BANZEL-treated patients had a 42.5% median reduction and placebo-treated
patients had a 1.4% median increase in tonic-atonic ("drop attacks")
seizure frequency per 28 days in the double-blind phase relative to the
baseline phase (p<0.0001).
An improvement in seizure severity was observed in 53.4% of the
BANZEL-treated patients compared to 30.6% of the placebo-treated
patients in the Seizure Severity Rating from the Global Evaluation of
the patient's condition (documented by the parent/guardian). There was
a significant difference between the two treatment groups in favor of
Banzel™ Important Safety Information
Use of Banzel (rufinamide) has been associated with central nervous
system-related adverse reactions, such as somnolence or fatigue,
coordination abnormalities, dizziness, gait disturbances, and ataxia.
Banzel is contraindicated for patients with Familial Short QT syndrome,
family history of short QT syndrome, presence, or history of short QT
interval; and patients who are hypersensitive to rufinamide, triazole
derivatives or any of the excipients.
In all patients with epilepsy treated with Banzel in double-blind,
adjunctive therapy studies, the most commonly observed adverse
reactions were headache, dizziness, fatigue, somnolence, and nausea.
About Eisai Corporation of North America
Eisai Inc. was established in 1995 and is ranked among the top-20 U.S.
pharmaceutical companies (based on retail sales). The company began
marketing its first product in the United States in 1997 and has
rapidly grown to become a fully integrated pharmaceutical business.
Eisai's areas of commercial focus include neurology, gastrointestinal
disorders and oncology/critical care. The company serves as the U.S.
pharmaceutical operation of Eisai Co., Ltd., a research-based human health care (hhc) company that discovers, develops and markets products throughout the
world. Eisai has a global product creation organization that includes
U.S. - based R&D facilities in Massachusetts, New Jersey, North
Carolina and Pennsylvania as well as manufacturing facilities in
Maryland and North Carolina. The company's areas of R&D focus include
neuroscience, oncology, vascular, inflammatory and immunological
reaction, and antibody-based programs.
Eisai established Eisai Limited Canada in 2010. As a wholly-owned
subsidiary of Eisai Inc., Eisai Limited is based in Mississauga,
Ontario, one of the largest biopharmaceutical clusters and medical
communities in North America.
Eisai acquired an exclusive worldwide license to develop, use,
manufacture and market Banzel for any human therapeutic use with the
exception of bipolar mood disorder, anxiety disorders and
ophthalmologic disorders from Novartis Pharma AG in 2004. BANZEL™ is a trademark of Novartis Pharma AG, used under license.
SOURCE Eisai Limited Canada
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