− TECFIDERA Treatment Significantly Reduced
Time to First Relapse vs. Glatiramer Acetate, Interferon β and
Teriflunomide and Showed Comparable Efficacy to Fingolimod in Data
Analysis from MSBase Registry −
− Benefit-Risk Profile of TECFIDERA Remains
Favorable Up to Nine Years −
New real-world and clinical evidence demonstrates that
TECFIDERA® (dimethyl fumarate) consistently delivered strong,
sustained efficacy in newly-diagnosed and previously treated
patients with relapsing-remitting multiple sclerosis (RRMS) and
affirms its well-characterized safety profile in patients who have
had up to nine years of treatment. Biogen (NASDAQ: BIIB) will
present these data at the 32nd Congress of the European Committee
for Treatment and Research in Multiple Sclerosis (ECTRIMS) in
London.
“As we continue to gather both clinical and real-world data,
evidence shows that TECFIDERA consistently demonstrates strong
efficacy in reducing MS disease activity over the long term,” said
Ralph Kern, M.D., senior vice president, Worldwide Medical, Biogen.
“The findings presented at ECTRIMS confirm the results we observed
in the TECFIDERA clinical trial program, further supporting its
early use to improve outcomes for people living with MS.”
Comparative Real-World Data Echo Strong Efficacy of TECFIDERA
Observed in Clinical TrialsReal-world evidence affirms the
positive effects of TECFIDERA treatment observed in clinical
trials, and demonstrates effectiveness versus multiple MS
therapies.
Using data sourced from the global MSBase registry and
propensity score matching, researchers compared relapse rates and
discontinuation outcomes in 415 TECFIDERA-treated patients to those
treated with another widely-used disease-modifying therapy
(fingolimod, teriflunomide, interferon β and glatiramer acetate).
MSBase is an ongoing, longitudinal, observational registry that
includes data from nearly 40,000 MS patients across 72
countries.
Real-world evidence from the MSBase analysis shows significant
benefits with TECFIDERA on time to first relapse relative to
interferon β (26%; hazard ratio [HR] 0.74; 95% confidence interval
[CI] 0.57, 0.97), glatiramer acetate (28%; HR 0.72; 95% CI 0.54,
0.95) and teriflunomide (34%; HR 0.66; 95% CI 0.45, 0.99). Time to
first relapse between TECFIDERA and fingolimod was similar.
“The MSBase registry is one of the largest sources of real-world
data, contributed by physicians with the ultimate goal of improving
MS quality of care,” said professor Helmut Butzkueven, joint
director of the Multiple Sclerosis Service at the Royal Melbourne
Hospital and associate professor in the Department of Medicine,
University of Melbourne. “When we conducted this comparative
effectiveness research, propensity score matching helped ensure the
similarity of the patient populations, which strengthened the
analysis. The data showed that TECFIDERA significantly reduced the
time to first relapse compared to platform therapies and
teriflunomide and had comparable efficacy to fingolimod.”
The MSBase analysis also evaluated two secondary endpoints,
annualized relapse rate (ARR) and treatment persistence. Longer
follow-up of TECFIDERA in the real-world setting will strengthen
this analysis and may clarify the effects seen on ARR across
treatment groups. An increase of treatment discontinuation with
TECFIDERA relative to fingolimod and interferon was also observed.
A separate real-world retrospective analysis of TECFIDERA patients
presented at ECTRIMS suggests that providing patient coaching can
offer a potentially effective means to reduce treatment
discontinuations.
Additional efficacy data presented at ECTRIMS include:
- New U.S. health claims data from a
large commercial insurance database, which demonstrate the
real-world effectiveness of TECFIDERA compared to other MS
therapies, as supported by the MSBase registry. A new analysis of
these data also shows consistent results in a subgroup of
newly-diagnosed patients.
- Data from the ongoing Phase 3 ENDORSE
study that show the ARR and 24-week confirmed disability
progression remained low in newly-diagnosed patients treated with
TECFIDERA over a minimum of seven years.
Favorable Benefit-Risk Profile Strengthened by Nine Years of
Treatment DataThe safety profile of TECFIDERA remains unchanged
and the overall benefit-risk remains favorable, as demonstrated by
up to nine years of clinical study results and real-world evidence
presented at the congress. Further, the data continue to
substantiate current guidance for monitoring absolute lymphocyte
counts (ALC) to effectively identify patients at risk of severe and
prolonged lymphopenia.
A List of TECFIDERA ECTRIMS Data Presentations
Includes:
- Poster Session 1 – Thursday, 15
September – 15:45-17:00 PM BST
- Absolute Lymphocyte Count and
Lymphocyte Subset Profiles During Long-Term Treatment with
Delayed-Release Dimethyl Fumarate in Patients with
Relapsing-Remitting Multiple Sclerosis (P716)
- Seven-Year Follow-up of the Efficacy of
Delayed-Release Dimethyl Fumarate in Newly Diagnosed Patients With
Relapsing-Remitting Multiple Sclerosis: Integrated Analysis of
DEFINE, CONFIRM, and ENDORSE (P631)
- Poster Session 2 – Friday, 16 September
– 15:30-17:00 PM BST
- Comparative Analysis of Multiple
Sclerosis Outcomes in Dimethyl Fumarate-Treated Patients Relative
to Propensity Matched Fingolimod, Interferon, Glatiramer Acetate,
or Teriflunomide (P1157)
- The Potential of Individualized Patient
Coaching to Optimize Treatment With Delayed-Release Dimethyl
Fumarate: A Retrospective Analysis of Patients With Multiple
Sclerosis Treated in a Real-World Setting (P1214)
- ePosters – Available in ECTRIMS Online
Library and App
- Annual Relapse Rates in Multiple
Sclerosis Patients Treated with Different Disease-Modify Therapies
– Findings from a Real World Setting (EP1481)
- Effect of Delayed-Release Dimethyl
Fumarate on Lymphocyte Subsets in Patients with Relapsing Multiple
Sclerosis: A Retrospective, Multicentre, Observational Study
(REALIZE) (EP1495)
About ENDORSEENDORSE is an ongoing global, dose-blind,
Phase 3 extension study to determine the long-term safety and
efficacy of TECFIDERA (240 mg, BID or TID). The study has enrolled
1,738 patients with RRMS who completed the DEFINE or CONFIRM
studies. Patients who received two years of TECFIDERA in DEFINE and
CONFIRM continued on the same dose (BID or TID) in ENDORSE.
Patients who previously received placebo or glatiramer acetate
(CONFIRM only) were randomized 1:1 to TECFIDERA BID or TID.
Following TECFIDERA approval at a dose of 240 mg BID, all subjects
continuing in this study received open-label TECFIDERA 240 mg BID.
Patients participating in ENDORSE will be followed for up to eight
years.
The primary objective of the study is to evaluate the long-term
safety profile of TECFIDERA. Secondary objectives include:
long-term efficacy of TECFIDERA on clinical outcomes and MS brain
lesions on MRI scans; and effects of TECFIDERA on quality of life
measurements.
About TECFIDERA®TECFIDERA is an oral therapy for
relapsing forms of MS, including relapsing-remitting MS, the
most common form of MS. TECFIDERA is currently approved in 24
countries including the United States, the European Union, Canada,
Australia and Switzerland. Through a robust clinical trial program
and commercial launches starting with the United States in March
2013, more than 215,000 patients have been treated with TECFIDERA
worldwide.1
TECFIDERA has been proven to reduce the rate of MS relapses,
slow the progression of disability, and the number of MS brain
lesions, while demonstrating a favorable benefit-risk profile in a
broad range of patients with relapsing forms of MS. 2 In clinical
trials, the most common adverse events associated with TECFIDERA
were flushing and gastrointestinal (GI) events. Other side effects
included a decrease in mean lymphocyte counts during the first year
of treatment, which then plateaued. TECFIDERA is contraindicated in
patients with a known hypersensitivity to dimethyl fumarate or any
of the excipients of TECFIDERA. Rare cases of PML have been seen
with TECFIDERA patients in the setting of prolonged moderate to
severe lymphopenia.
The efficacy and safety of TECFIDERA have been studied in a
large, global clinical program, which includes an ongoing long-term
extension study. It is believed that TECFIDERA treats 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.
For additional important safety information, and the United
States full prescribing information, please visit
www.tecfidera.com.
About BiogenThrough cutting-edge science and medicine,
Biogen discovers, develops and delivers worldwide innovative
therapies for people living with serious neurological, autoimmune
and rare diseases. Founded in 1978, Biogen is one of the world’s
oldest independent biotechnology companies and patients worldwide
benefit from its leading multiple sclerosis and innovative
hemophilia therapies. For more information, please
visit www.biogen.com. Follow us on Twitter.
Safe HarborThis press release includes forward-looking
statements, including statements about the benefits of TECFIDERA in
MS patients over the long-term. These forward-looking statements
may be accompanied by such words as "anticipate," "believe,"
"estimate," "expect," "forecast," "intend," "may," "plan," "will,"
and other words and terms of similar meaning. You should not place
undue reliance on these statements. Drug development and
commercialization involve a high degree of risk and only a small
number of research and development programs result in
commercialization of a product. Factors which could cause actual
results to differ materially from our current expectations include
the risk that unexpected concerns may arise from additional data or
analysis, regulatory authorities may require additional information
or further studies, or may fail to approve or may delay approval of
our drug candidates or expansion of our product labeling, or we may
encounter other unexpected hurdles. For more detailed information
on the risks and uncertainties associated with our drug development
and commercialization activities, please review the Risk Factors
section of our most recent annual or quarterly report filed with
the Securities and Exchange Commission. 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 Combined post-marketing and clinical trials exposure to
TECFIDERA as of 30 June 2016.2 TECFIDERA is approved in the
European Union for relapsing-remitting multiple sclerosis.
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BiogenMEDIA CONTACT:Lindsey Smith,
+1-781-464-3260public.affairs@biogen.comorINVESTOR CONTACT:Matt
Calistri, +1-781-464-2442IR@biogen.com
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