Biogen Idec’s TECFIDERA™ (Dimethyl Fumarate) Approved in US as a First-Line
Oral Treatment for Multiple Sclerosis
- Offers a Broad Spectrum of Patients with Relapsing Forms of MS an Effective
and Convenient Treatment Option -
- Reduces Relapses and Disability Progression -
- Strengthens Biogen Idec’s Portfolio of Innovative Treatments for People
Living with MS -
WESTON, Mass. -- March 27, 2013
Today Biogen Idec (NASDAQ: BIIB) announced that the U.S. Food and Drug
Administration (FDA) has approved TECFIDERA™ (dimethyl fumarate), a new
first-line oral treatment for people with relapsing forms of multiple
sclerosis (MS). Biogen Idec will make this oral capsule available to people
living with MS in the United States in the coming days.
TECFIDERA has been clinically proven to significantly reduce important
measures of disease activity, including relapses and development of brain
lesions, as well as to slow disability progression over time, while
demonstrating a favorable safety and tolerability profile.
“With the FDA approval of TECFIDERA, we will offer the MS community a
treatment with strong 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 George
A. Scangos, Ph.D., chief executive officer of Biogen Idec. “Biogen Idec is
committed to delivering innovative treatments and setting new standards for
the next generation of medicines. We believe TECFIDERA will raise expectations
for what people living with MS can achieve with their therapy.”
The FDA approval of TECFIDERA is based on data from a robust clinical
development program that included DEFINE and CONFIRM, two global Phase 3
studies that enrolled more than 2,600 patients. In the ongoing extension
study, ENDORSE, some patients receiving TECFIDERA 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=0.0020) compared to
placebo at two years. While not statistically significant, TECFIDERA showed a
21 percent reduction in 12-week confirmed disability progression in CONFIRM.
Both studies also showed that TECFIDERA significantly reduced lesions in the
brain compared to placebo, as measured by magnetic resonance imaging (MRI).
“In clinical trials, patients treated with dimethyl fumarate had less disease
activity when compared to patients on placebo – whether they were in the early
stages of MS or had more established disease,” said Robert Fox, M.D., medical
director of the Mellen Center for Multiple Sclerosis at Cleveland Clinic, lead
investigator of the CONFIRM study, and a paid advisor for Biogen Idec for
projects not related to TECFIDERA clinical development. “Withthe efficacy,
safety and tolerability measures seen in CONFIRM,this drug provides
physicians with animportant additionaltreatmentoptionfor their patients
across the MS spectrum.”
The most common side effects associated with TECFIDERA are flushing and
gastrointestinal (GI) events (i.e., diarrhea, nausea and abdominal pain). In
clinical studies, flushing symptoms usually began soon after initiating
treatment, were mostly mild to moderate, and usually improved or resolved over
time. The incidence of GI events was higher early in the course of treatment
(primarily in the first month) and decreased over time. Overall, clinical
trial discontinuations due to flushing and GI events were low.
TECFIDERA may decrease lymphocyte counts in some patients. In clinical
studies, mean lymphocyte counts decreased during the first year of treatment
and then remained stable. The incidence of infections and serious infections
was similar in TECFIDERA-treated patients and those on placebo. There were no
opportunistic infections in TECFIDERA-treated patients. In patients with low
lymphocyte counts, there was no increased incidence in serious infections.
Patients taking TECFIDERA should have a complete blood count (CBC) before
starting treatment to measure lymphocyte counts. A follow up CBC is
recommended annually and at the discretion of the treating physician.
“We are pleased to see a new, needed treatment option available to people
living with MS,” said Dr. Timothy Coetzee, chief research officer at the
National MS Society. “With the collaborative focus on MS research around the
world, it is an exceptionally encouraging time for those who have been
diagnosed with relapsing forms of MS.”
TECFIDERA marks the fourth therapy Biogen Idec offers worldwide to people
living with MS.
Additional TECFIDERA Updates
*On March 22, 2013 the Committee for Medicinal Products for Human Use
(CHMP) in the European Union (EU) issued a positive opinion recommending a
marketing authorization be granted for TECFIDERA as a first-line oral
treatment for adults with relapsing-remitting multiple sclerosis (RRMS).
The CHMP's recommendation has now been referred to the European Commission
(EC), which grants marketing authorization for medicines in the European
*On March 19, 2013, the United States Patent and Trademark Office issued a
patent covering the dosing regimen of daily administration of 480 mg of
TECFIDERA. This patent will expire in 2028.
*The European Patent Office recently determined that Biogen Idec’s
application for a patent covering the dosing regimen of daily
administration of 480 mg of TECFIDERA is allowable. Once granted, the EU
patent would also expire in 2028.
TECFIDERA is also currently under review by regulatory authorities in
Australia, Canada and Switzerland.
For more information on TECFIDERA, prescribing information and financial
assistance programs go to TECFIDERA.com or biogenidec.com.
For members of the media interested in more information and additional
resources, please visit biogenidec.com/us_media_corner.
TECFIDERA delayed-release capsules are indicated for the treatment of patients
with relapsing forms of MS. TECFIDERA has been proven to reduce MS relapses,
progression of disability and MS brain lesions. The efficacy and safety of
TECFIDERA has been studied in a large, global clinical program with more than
3,600 MS patients, which includes an ongoing long-term extension study. It is
believed that TECFIDERA provides a new approach to treating MS by activating
the Nrf2 pathway, although its exact mechanism of action is unknown. This
pathway provides a way for cells in the body to defend themselves against
inflammation and oxidative stress caused by conditions like MS.
The starting dose for TECFIDERA is 120mg twice a day orally. After seven
days, the recommended dose increases to 240mg twice a day orally.
The most common adverse reactions for TECFIDERA were flushing, mostly mild to
moderate in nature, and GI events (i.e., diarrhea, nausea, abdominal pain).
These events are most common at the start of therapy and usually decrease over
TECFIDERA may decrease lymphocyte counts. Before starting treatment with
TECFIDERA, a recent CBC (i.e., within six months) should be available. A CBC
is recommended annually and as clinically indicated. TECFIDERA has not been
studied in patients with pre-existing low lymphocyte counts and caution should
be exercised when treating these patients.
TECFIDERA has a Pregnancy Category C. Before starting treatment with
TECFIDERA, women should talk to their doctor if they are pregnant or planning
to become pregnant.
For complete TECFIDERA prescribing information, please visit TECFIDERA.com.
Biogen Idec Patient Support
As part of its ongoing commitment to the MS community, Biogen Idec provides a
variety of support services for patients and caregivers through MS
ActiveSource^®. These world-class services are thoughtfully crafted around the
informational, emotional, financial and logistical needs that come with living
MS ActiveSourceis available via phone (Monday – Friday 8:30 a.m. – 8 p.m. ET)
at 1-800-456-2255 or via web at MSActiveSource.com.
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 more than 2.1 million people worldwide.^1 Best current estimates
indicate that there are at least 400,000 people with MS in the United
States.^2 RRMS is the most common form of the disease, accounting for 85
percent of cases, and is characterized by clearly defined acute attacks with
full recovery or with residual deficit upon recovery.^3
Through cutting-edge science and medicine,Biogen Idecdiscovers, develops and
delivers to patients worldwide innovative therapies for the treatment of
neurodegenerative diseases, hemophilia and autoimmune disorders. Founded in
1978,Biogen Idecis the world’s oldest independent biotechnology company.
Patients worldwide benefit from its leading multiple sclerosis therapies, and
the company generates more than$5 billionin annual revenues. For product
labeling, press releases and additional information about the company, please
This press release contains forward-looking statements, including statements
about the development, commercialization and therapeutic impact of TECFIDERA.
These forward-looking statements may be accompanied by such words as
“anticipate,” “believe,” “could,” “estimate,” “expect,” “forecast,” “intend,”
“may,” “plan,” “potential,” “project,” “target,” “will” and other words and
terms of similar meaning. 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 uncertainty of success in commercialization of TECFIDERA, which may
be impacted by, among other things, the medical community’s acceptance of
TECFIDERA, the effectiveness of our sales force and marketing efforts, product
competition in the MS market, including the possibility of future competition
from generic versions of TECFIDERA, problems with our manufacturing processes
and our reliance on third parties to manufacture and supply TECFIDERA, the
occurrence of adverse safety events, changes in the availability of
reimbursement for our products, adverse market and economic conditions,
failure to comply with government regulation, our ability to obtain regulatory
approvals in jurisdictions outside of the U.S., our ability to protect our
intellectual property rights and have sufficient rights to market our products
together with the cost of doing so, product liability claims 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 U.S. Securities and Exchange Commission (SEC).
These statements are based on our current beliefs and expectations and speak
only as of the date of this press release. We do not undertake any obligation
to publicly update any forward-looking statements.
^1 National Multiple Sclerosis Society (NMSS). FAQs about MS. Date accessed:
March 27, 2013.
^2 National Multiple Sclerosis Society (NMSS). MS Prevalence. Date accessed:
March 27, 2013.
^3 National Multiple Sclerosis Society (NMSS). For People with Relapsing MS.
Date accessed: March 27, 2013.
Kate Niazi-Sai, +1 781-464-3260
Monique da Silva, +1 781-464-3260
Kia Khaleghpour, +1 781-464-2442
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