The CHMP's recommendation is now referred to the
“With the CHMP’s positive opinion for TECFIDERA, we are one step closer
to offering the European MS community a treatment with compelling
efficacy and a favorable safety profile in the convenience of a pill – a
combination we believe will have a significant positive impact on the
way people live with this chronic disease,” said
The CHMP opinion for TECFIDERA is based on data from a large clinical development program that included two global Phase 3 studies, DEFINE and CONFIRM, 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 percent (p<0.0001), the annualized relapse rate (ARR) by 53 percent (p<0.0001), and 12-week confirmed disability progression, as measured by the Expanded Disability Status Scale (EDSS), by 38 percent (p=0.0050) compared to placebo at two years. In CONFIRM, twice-daily TECFIDERA significantly reduced ARR by 44 percent (p<0.0001) and the proportion of patients who relapsed by 34 percent (p<0.0001) compared to placebo at two years. While not statistically significant, TECFIDERA showed a 21 percent reduction in 12-week confirmed disability progression in CONFIRM. In addition, both studies showed TECFIDERA significantly reduced lesions in the brain compared to placebo, as measured by magnetic resonance imaging (MRI).
“Clinical studies demonstrated TECFIDERA was an effective therapy with a
favorable safety profile for people with relapsing-remitting MS,” said
The most common side effects associated with TECFIDERA seen in clinical trials are flushing and gastrointestinal (GI) events (i.e., diarrhea, nausea, and abdominal pain). Other side effects include a decrease in mean lymphocyte counts during the first year of treatment, which then plateaued. There was no increased risk of malignancy or serious infections associated with TECFIDERA treatment, and no opportunistic infections were observed.
TECFIDERA™ (dimethyl fumarate) is an oral therapeutic candidate for the treatment of multiple sclerosis (MS). TECFIDERA is the only currently known investigational compound for the treatment of relapsing-remitting MS that has experimentally demonstrated activation of the Nrf-2 pathway. This pathway provides a way for cells in the body to defend themselves against inflammation and oxidative stress caused by conditions like MS.
In 2011 and 2012,
About Multiple Sclerosis
Multiple sclerosis (MS) is a chronic, often disabling disease that
attacks the central nervous system (CNS), which is made up of the brain,
spinal cord and optic nerves. Symptoms may be mild or severe, ranging
from numbness in the limbs to paralysis or loss of vision. The
progression, severity, and specific symptoms of MS are unpredictable and
vary from one person to another. MS affects an estimated 2.5 million
people worldwide,1 with approximately 400,000 sufferers in
About Biogen Idec
Through cutting-edge science and medicine, Biogen Idec discovers, develops and delivers to patients worldwide innovative therapies for the treatment of neurodegenerative diseases, hemophilia and autoimmune disorders. Founded in 1978, Biogen Idec 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 product labeling, press releases and additional information about the company, please visit www.biogenidec.com.
This press release contains forward-looking statements, including
statements about anticipated regulatory approvals and the potential
therapeutic impact of TECFIDERA. These statements may be identified by
words such as "believe," "expect," "may," "plan," "potential," "will"
and similar expressions, and are based on our current beliefs and
expectations. You should not place undue reliance on these statements.
These statements involve risks and uncertainties that could cause actual
results to differ materially from those reflected in such statements,
including risks associated with obtaining regulatory approval,
uncertainty of success in commercialization of TECFIDERA and the other
risks and uncertainties that are described in the Risk Factors section
of our most recent annual or quarterly report and in other reports we
have filed with the
2 European Multiple Sclerosis Platform. MS Fact Sheet.
US MEDIA CONTACT:
Kate Niazi-Sai, +1-781-464-3260
EX-US MEDIA CONTACT:
Biogen Idec International
Shannon Altimari, +41 41 392 16 77
Kia Khaleghpour, +1-781-464-2442