TECFIDERA™,
formerly BG-12, provides a combination of proven efficacy and favourable safety
profile
formerly BG-12, provides a combination of proven efficacy and favourable safety
profile
MISSISSAUGA, ON – April 9, 2013 – Today, Biogen Idec Canada announced the
Health Canada approval of TECFIDERA™ (dimethyl fumarate) delayed-release
capsules, formerly BG-12, as a first-line oral treatment for adults with
relapsing-remitting multiple sclerosis (RRMS). TECFIDERA is indicated as monotherapy
for the treatment of RRMS to reduce the frequency of clinical exacerbations and
to delay the progression of disability.[i]
Health Canada approval of TECFIDERA™ (dimethyl fumarate) delayed-release
capsules, formerly BG-12, as a first-line oral treatment for adults with
relapsing-remitting multiple sclerosis (RRMS). TECFIDERA is indicated as monotherapy
for the treatment of RRMS to reduce the frequency of clinical exacerbations and
to delay the progression of disability.[i]
“The approval of dimethyl fumarate is a
significant advancement for people living with multiple sclerosis, helping
address many treatment barriers that may affect medical intervention,”
said Dr. Marcelo Kremenchutzky, lead clinical researcher and Director of the
Multiple Sclerosis Clinic, London, Ontario. “With this new oral medication,
Canadian patients have access to a disease-modifying treatment that offers
convenient oral administration coupled with clinically proven effectiveness and
favorable safety profile.”
significant advancement for people living with multiple sclerosis, helping
address many treatment barriers that may affect medical intervention,”
said Dr. Marcelo Kremenchutzky, lead clinical researcher and Director of the
Multiple Sclerosis Clinic, London, Ontario. “With this new oral medication,
Canadian patients have access to a disease-modifying treatment that offers
convenient oral administration coupled with clinically proven effectiveness and
favorable safety profile.”
Findings from both Phase III two-year studies,
DEFINE and CONFIRM, showed that TECFIDERA demonstrated robust clinical and
radiological efficacy over time in a broad range of patients with RRMS, while
maintaining consistently favourable safety and tolerability.[ii]
DEFINE and CONFIRM, showed that TECFIDERA demonstrated robust clinical and
radiological efficacy over time in a broad range of patients with RRMS, while
maintaining consistently favourable safety and tolerability.[ii]
“We welcome the approval of an additional
treatment option for people living with relapsing forms of MS,” said Sylvia
Leonard, President, Ontario and Nunavut Division and National Vice-President,
Programs and Services of the Multiple Sclerosis Society of Canada. “As with any
new therapy, we recommend that people with MS contact their physician to find
out more information.”
treatment option for people living with relapsing forms of MS,” said Sylvia
Leonard, President, Ontario and Nunavut Division and National Vice-President,
Programs and Services of the Multiple Sclerosis Society of Canada. “As with any
new therapy, we recommend that people with MS contact their physician to find
out more information.”
MS attacks the protective covering, or myelin,
around the nerves of the central nervous system (CNS).[iii] Nerve damage, caused by inflammation, occurs when the
body’s immune cells attacks the nervous system along any area of the brain,
optic nerve, and spinal cord.[iv]
around the nerves of the central nervous system (CNS).[iii] Nerve damage, caused by inflammation, occurs when the
body’s immune cells attacks the nervous system along any area of the brain,
optic nerve, and spinal cord.[iv]
TECFIDERA is the only compound for the treatment of
multiple sclerosis (MS) known to activate the Nrf2 pathway, in vitro and
in vivo animals and humans, a central mechanism of cellular defense.[v] TECFIDERA may work by changing the way the body’s
immune system works, to help keep it from further damaging the brain and spinal
cord, although the exact mechanism is not known.[vi]
multiple sclerosis (MS) known to activate the Nrf2 pathway, in vitro and
in vivo animals and humans, a central mechanism of cellular defense.[v] TECFIDERA may work by changing the way the body’s
immune system works, to help keep it from further damaging the brain and spinal
cord, although the exact mechanism is not known.[vi]
“We believe TECFIDERA will raise expectations
for what people living with MS can achieve from their therapy,” said Paul
Petrelli, Managing Director, Biogen Idec Canada. “TECFIDERA marks the fourth
therapy we provide in Canada to treat this highly complex disease. No one is
doing more for people living with MS and Biogen Idec is fully committed to
delivering innovative treatments, as well as best-in-class support services for
MS patients.”
for what people living with MS can achieve from their therapy,” said Paul
Petrelli, Managing Director, Biogen Idec Canada. “TECFIDERA marks the fourth
therapy we provide in Canada to treat this highly complex disease. No one is
doing more for people living with MS and Biogen Idec is fully committed to
delivering innovative treatments, as well as best-in-class support services for
MS patients.”
Data proves efficacy in two of the largest Phase III
studies ever in MS
studies ever in MS
The Health Canada approval of TECFIDERA is
based on data from DEFINE and CONFIRM, two global Phase 3 studies, involving
more than 2,600 RRMS patients, as well as an ongoing extension study in which
some patients have been followed for more than four years. In DEFINE,
TECFIDERA, administered twice daily, significantly reduced the proportion of
patients who relapsed by 49 per cent (p<0.0001), the annualized relapse rate
(ARR) by 53 per cent (p<0.0001), and 12-week confirmed disability
progression, as measured by the Expanded Disability Status Scale (EDSS), by 38
per cent (p=0.0050) compared to placebo at two years. In CONFIRM, twice-daily
TECFIDERA significantly reduced ARR by 44 per cent (p<0.0001) and the
proportion of patients who relapsed by 34 per cent (p=0.002) compared to
placebo at two years. While not statistically significant, TECFIDERA showed a
21 per cent reduction in 12-week confirmed disability progression in CONFIRM.
Both studies also showed TECFIDERA significantly reduced lesions in the brain
compared to placebo, as measured by magnetic resonance imaging (MRI).[vii]
based on data from DEFINE and CONFIRM, two global Phase 3 studies, involving
more than 2,600 RRMS patients, as well as an ongoing extension study in which
some patients have been followed for more than four years. In DEFINE,
TECFIDERA, administered twice daily, significantly reduced the proportion of
patients who relapsed by 49 per cent (p<0.0001), the annualized relapse rate
(ARR) by 53 per cent (p<0.0001), and 12-week confirmed disability
progression, as measured by the Expanded Disability Status Scale (EDSS), by 38
per cent (p=0.0050) compared to placebo at two years. In CONFIRM, twice-daily
TECFIDERA significantly reduced ARR by 44 per cent (p<0.0001) and the
proportion of patients who relapsed by 34 per cent (p=0.002) compared to
placebo at two years. While not statistically significant, TECFIDERA showed a
21 per cent reduction in 12-week confirmed disability progression in CONFIRM.
Both studies also showed TECFIDERA significantly reduced lesions in the brain
compared to placebo, as measured by magnetic resonance imaging (MRI).[vii]
About TECFIDERA
TECFIDERA provides a new approach to treating
MS and is the only known compound to activate the Nrf2 pathway, although the
exact mechanism of action is unknown. This pathway provides a way for cells in
the body to defend against inflammation and oxidative stress caused by
conditions like MS. Research in vivo and in vitro in animals
suggests that TECFIDERA can reduce the impact of inflammatory cells on the CNS
and may provide protection against harmful agents in CNS cells. These effects
may enhance the CNS cells’ ability to reduce inflammatory stress that plays a
role in the physiological processes associated with MS.[viii]
MS and is the only known compound to activate the Nrf2 pathway, although the
exact mechanism of action is unknown. This pathway provides a way for cells in
the body to defend against inflammation and oxidative stress caused by
conditions like MS. Research in vivo and in vitro in animals
suggests that TECFIDERA can reduce the impact of inflammatory cells on the CNS
and may provide protection against harmful agents in CNS cells. These effects
may enhance the CNS cells’ ability to reduce inflammatory stress that plays a
role in the physiological processes associated with MS.[viii]
Important Safety Information
The most common side effects associated with
TECFIDERA seen in clinical trials are flushing and gastrointestinal events such
as diarrhea, nausea, and abdominal pain. Other side effects include a decrease
in mean lymphocyte counts during the first year of treatment, which then
plateaued, and elevations of hepatic transaminases primarily during the first
six months of treatment. Reports of protein in the urine were slightly higher
for patients treated with TECFIDERA although the significance of these clinical
observations is unknown. There was no increased risk of malignancy, infections
or serious infections associated with TECFIDERA treatment.
TECFIDERA seen in clinical trials are flushing and gastrointestinal events such
as diarrhea, nausea, and abdominal pain. Other side effects include a decrease
in mean lymphocyte counts during the first year of treatment, which then
plateaued, and elevations of hepatic transaminases primarily during the first
six months of treatment. Reports of protein in the urine were slightly higher
for patients treated with TECFIDERA although the significance of these clinical
observations is unknown. There was no increased risk of malignancy, infections
or serious infections associated with TECFIDERA treatment.
About Biogen Idec ONE™
Patient Services Program
Patient Services Program
Biogen Idec Canada is
committed to delivering best-in-class quality and services to care for MS
patients. All TECFIDERA patients will have access to a Regional Support Nurse
in their region that will provide personalized support for patients and
healthcare providers in all aspects of patient care, from treatment to
reimbursement. This enables healthcare providers and patients the opportunity
to work directly with one nurse per region across all Biogen Idec Canada MS
products, which is intended to enhance the quality and continuity of care that
we can provide to patients. For more information about the Biogen Idec
ONE™ program, call 1-855-MSONE-00 or 1-855-676-6300.
committed to delivering best-in-class quality and services to care for MS
patients. All TECFIDERA patients will have access to a Regional Support Nurse
in their region that will provide personalized support for patients and
healthcare providers in all aspects of patient care, from treatment to
reimbursement. This enables healthcare providers and patients the opportunity
to work directly with one nurse per region across all Biogen Idec Canada MS
products, which is intended to enhance the quality and continuity of care that
we can provide to patients. For more information about the Biogen Idec
ONE™ program, call 1-855-MSONE-00 or 1-855-676-6300.
About Multiple Sclerosis
MS is an unpredictable, often debilitating
disease of the CNS that attacks the protective covering, or myelin, of the
brain and spinal cord, causing inflammation and damage.[ix] When this occurs, the normal flow of nerve impulses along
nerve fibres, or axons, becomes disrupted.[x] The result of
damaged myelin may be a wide variety of MS symptoms including fatigue,
weakness, muscle spasms, pain, tremors, double vision, bladder and bowel
dysfunction, cognitive deficits and loss of mobility, among other problems.[xi],[xii]
disease of the CNS that attacks the protective covering, or myelin, of the
brain and spinal cord, causing inflammation and damage.[ix] When this occurs, the normal flow of nerve impulses along
nerve fibres, or axons, becomes disrupted.[x] The result of
damaged myelin may be a wide variety of MS symptoms including fatigue,
weakness, muscle spasms, pain, tremors, double vision, bladder and bowel
dysfunction, cognitive deficits and loss of mobility, among other problems.[xi],[xii]
MS is most often diagnosed in young adults,
aged 15 to 40, but sometimes affects children as young as two years old.[xiii] The course of MS is heterogeneous, but generally occurs
over 30 to 40 years, and is characterized by multiple neurologic deficits,
decreased quality of life[xiv] and significant
socioeconomic burden.[xv]
aged 15 to 40, but sometimes affects children as young as two years old.[xiii] The course of MS is heterogeneous, but generally occurs
over 30 to 40 years, and is characterized by multiple neurologic deficits,
decreased quality of life[xiv] and significant
socioeconomic burden.[xv]
Multiple Sclerosis in Canada
Canada is known for having one of the highest
prevalence of MS in the world.[xvi] Currently, more
than two million people are estimated to suffer with MS worldwide,[xvii] including between 55,000 and 75,000 Canadians. The overall
weighted estimate of MS rates in Canada is 240 per 100,000 people[xviii] causing three or more people per day to be diagnosed with
MS.[xix]
prevalence of MS in the world.[xvi] Currently, more
than two million people are estimated to suffer with MS worldwide,[xvii] including between 55,000 and 75,000 Canadians. The overall
weighted estimate of MS rates in Canada is 240 per 100,000 people[xviii] causing three or more people per day to be diagnosed with
MS.[xix]
About Biogen Idec Canada
Biogen Idec Canada is the Canadian affiliate of
Biogen Idec. Through cutting-edge science and medicine, Biogen Idec discovers,
develops, manufactures and markets therapies for diseases with a focus on
neurology, immunology and hemophilia. Founded in 1978, with a presence in
Canada since 1998, it is the world’s oldest independent biotechnology company.
Patients worldwide benefit from its leading multiple sclerosis therapies and
the company generates more than $5 billion in annual revenues. For press
releases and additional information about the company, please visit www.biogenidec.com.
Biogen Idec. Through cutting-edge science and medicine, Biogen Idec discovers,
develops, manufactures and markets therapies for diseases with a focus on
neurology, immunology and hemophilia. Founded in 1978, with a presence in
Canada since 1998, it is the world’s oldest independent biotechnology company.
Patients worldwide benefit from its leading multiple sclerosis therapies and
the company generates more than $5 billion in annual revenues. For press
releases and additional information about the company, please visit www.biogenidec.com.
-30-
For more information or to arrange an interview, please contact:
Rick Maddalena
GCI Group (Canada)
416-486-7225
GCI GROUP : changeRULES
rickmaddalena | gcigroup
| consultant | phone: 416.486.7225 | fax:
416.486.9783 |
| consultant | phone: 416.486.7225 | fax:
416.486.9783 |
..
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