New Research Demonstrate Biogen’s Continued Commitment to Improve
Care of Patients with Multiple Sclerosis Across Treatment
Spectrum
Biogen Inc. (Nasdaq: BIIB) is highlighting new data that
demonstrate the potential benefits of treatment with TYSABRI®
(natalizumab), PLEGRIDY® (peginterferon beta-1a) and
AVONEX® (interferon beta-1a) in specific multiple
sclerosis (MS) patient populations. Results obtained in real-world
clinical practice are being presented at the 35th Congress of the
European Committee for Treatment and Research in MS (ECTRIMS) and
24th Annual Conference of Rehabilitation in MS in Stockholm
(September 11-13).
“Biogen’s long-standing leadership in MS presents an opportunity
to continue evolving the paradigm of care through continued
research of some of our most widely prescribed MS therapies,
including TYSABRI, PLEGRIDY and AVONEX,” said Alfred Sandrock, Jr.,
M.D., Ph.D., executive vice president and chief medical officer at
Biogen. “Through thoughtful and rigorous exploration of potential
new approaches, like TYSABRI extended interval dosing, we are
working to optimize patient outcomes.”
Data Further Support Early Treatment with TYSABRI and
Extended Interval Dosing Four-year data from the
observational, open-label, single-arm STRIVE study support the
real-world long-term effectiveness of TYSABRI in patients with
early relapsing MS, who are within three years from diagnosis and
are anti-JC virus antibody negative. Over the first two to four
years of treatment (n/N=110/157), 70.1 percent of patients in the
study achieved clinical NEDA (no evidence of disease activity),
defined as no relapses or 24-week confirmed disability worsening.
Additionally, 83.7 percent achieved MRI NEDA, defined as no
gadolinium-enhancing or new/newly enlarging T2 lesions, and more
than half (58 percent) achieved overall NEDA, which encompassed
both clinical and MRI NEDA. Results also show TYSABRI was
associated with significant improvements in disability and
cognitive performance.
The effectiveness of every six weeks (Q6W) dosing with
natalizumab was evaluated using data from the TYSABRI Observational
Program (TOP), an ongoing, real-world study of natalizumab-treated
patients. Analyses compared relapse outcomes in patients who
switched to natalizumab Q6W dosing after at least one year on every
four weeks (Q4W) dosing (n=135) to those who remained on the
approved Q4W dosing (n=135). After propensity score matching,
results indicate there was no significant difference in annualized
relapse rate or risk of relapse between the two groups. These data
complement the previously presented TOUCH database safety analysis
showing that natalizumab extended interval dosing (EID; average of
approximately six weeks) was associated with a significantly lower
risk of the rare but serious brain infection progressive multifocal
leukoencephalopathy (PML), compared to Q4W dosing. Biogen recently
completed enrollment for the Phase 3b NOVA study, a two-year,
randomized, prospective trial that will compare the effectiveness
of natalizumab Q4W versus Q6W after at least one year of Q4W
dosing.
Real-world Data Indicate Interferon Beta Treatment May
Not Impact Some Pregnancy/Infant
OutcomesAs women with MS are often diagnosed and treated
at child-bearing age, family planning is frequently an important
consideration for physicians and patients when choosing a treatment
path. New data from two real-world observational studies provide
further support that exposure to interferon beta treatment,
including PLEGRIDY and AVONEX, before conception and/or during
pregnancy is not expected to have an adverse effect on pregnancy or
infant growth outcomes.
Researchers utilized healthcare data from Nordic registers
(Finland and Sweden) to retrospectively analyze infant outcomes for
women with MS treated with interferon beta compared to women with
MS unexposed to disease-modifying therapies. Results show outcomes
were similar between the two groups, with no evidence that exposure
to interferon beta treatment before and/or during pregnancy
affected the weight or head circumference of infants at birth. Data
on pregnancy outcomes collected during the ongoing five-year
PLEGRIDY Observational Program (POP), which is evaluating the
long-term safety and effectiveness of PLEGRIDY in more than 1,200
relapsing MS patients worldwide, were consistent with previously
reported pregnancy outcomes from both the Nordic registers study
and the European Interferon Beta Pregnancy Registry.
Featured data presentation
details:
- Natalizumab is Associated with No Evidence of Disease Activity
and with Improvement in Disability and Cognitive Performance in
Anti–JC Virus Seronegative Patients with Early Relapsing-Remitting
Multiple Sclerosis: STRIVE 4-Year Results (P1348; Poster Session 3,
Friday, September 13, 12:15-2:15 p.m. CET)
- No Significant Difference in Relapse Outcomes in Patients
Switching to Natalizumab Extended Interval Dosing or Remaining on
Standard Interval Dosing: Propensity Score Comparative
Effectiveness Analysis of Patients in the TYSABRI Observational
Program (P1033, Poster Session 2, Thursday, September 12, 5:15-7:15
p.m. CET)
- Prevalence of Infant Outcomes at Birth After Exposure to
Interferon Beta Prior to or During Pregnancy: A Register-based
Cohort Study in Finland and Sweden Among Women with MS (P1144;
Poster Session 3, Friday, September 13, 12:15-2:15 p.m. CET)
- Safety, Pregnancy Outcomes, and Clinical Effectiveness of
Peginterferon Beta-1a for Patients with Newly Diagnosed and
Non-Newly Diagnosed Relapsing Multiple Sclerosis: Third Interim
Analysis of the Plegridy Observational Program (P1019; Poster
Session 2, Thursday, September 12, 5:15-7:15 p.m. CET)
About TYSABRI® TYSABRI is a
well-established relapsing multiple sclerosis (RMS) treatment that
has been proven in clinical trials to slow physical disability
progression, reduce the formation of new brain lesions and cut
relapses. TYSABRI is approved in 80 countries,
and over 200,000 people worldwide have been treated with
TYSABRI, with over 750,000 patient-years of
experience, based on clinical trials and prescription data.1
TYSABRI is indicated as monotherapy for the treatment of patients
with relapsing forms of MS. In the European Union, it is indicated
as single disease modifying therapy (DMT) in adults with highly
active relapsing-remitting MS (RRMS) for patients despite a full
and adequate course of treatment, with at least one DMT or patients
with rapidly evolving severe RRMS.
TYSABRI increases the risk of progressive multifocal
leukoencephalopathy (PML), a rare opportunistic viral infection of
the brain which has been associated with death or severe
disability. Risk factors that increase the risk of PML are the
presence of anti-JC virus antibodies, prior immunosuppressant use
and longer TYSABRI treatment duration. Patients who have all three
risk factors have the highest risk of developing PML.
TYSABRI also increases the risk of developing encephalitis and
meningitis caused by herpes simplex and varicella zoster viruses,
and serious, life-threatening and sometimes fatal cases have been
reported in the post-marketing setting in MS patients receiving
TYSABRI. Clinically significant liver injury, including acute liver
failure requiring transplant, has also been reported in the
post-marketing setting. Other serious adverse events that have
occurred in TYSABRI-treated patients include hypersensitivity
reactions (e.g., anaphylaxis) and infections, including
opportunistic and other atypical infections.
Please click here for Important Safety Information,
including Boxed Warning, and full Prescribing
Information, including Medication Guide for TYSABRI in
the U.S., or visit your respective country’s product website.
About PLEGRIDY® PLEGRIDY
is a subcutaneous pegylated interferon dosed once every two weeks
for relapsing forms of MS, including relapsing-remitting MS
(RRMS), the most common form of MS. PLEGRIDY is currently approved
in over 60 countries including the U.S., Canada, Australia
Switzerland and across the European Union. Nearly 50,000 people
worldwide have been treated with PLEGRIDY, with
over 88,000 patient-years of experience, based on
prescription data.2 Biogen continues to work toward making PLEGRIDY
available in additional countries across the globe.
The efficacy and safety of PLEGRIDY is supported by one of the
largest pivotal studies with interferons conducted in people living
with RRMS. In clinical studies, PLEGRIDY has been proven to
significantly reduce the rate of MS relapses, slow the progression
of disability, and reduce the number of MS brain lesions while
demonstrating a favorable safety profile for patients with
relapsing forms of MS. Side effects reported include liver
problems, including liver failure and increases in liver enzymes;
depression or suicidal thoughts; serious allergic reactions;
cardiac problems, including congestive heart failure; autoimmune
disorders; decreases in white blood cell or platelet counts; and
seizures. In clinical trials, the most common adverse events
associated with PLEGRIDY were injection site reactions and flu-like
symptoms. A list of adverse events can be found in the full
PLEGRIDY product labeling for each country where it is
approved.
Please click here for Important Safety
Information and full Prescribing Information,
including Medication Guide for PLEGRIDY in the U.S., or visit
your respective country’s product website.
About AVONEX® AVONEX is
one of the most prescribed treatments for relapsing forms of MS
worldwide and is currently approved in over 90 countries. Over
550,000 people worldwide have been treated with AVONEX, with
over 2.6 million patient-years of experience, based on
prescription data.3 AVONEX is indicated for the treatment of
patients with relapsing forms of MS to slow the accumulation of
physical disability and decrease the frequency of clinical
exacerbations. Patients with MS in whom efficacy has been
demonstrated include patients who have experienced a first clinical
episode and have MRI features consistent with MS.
Symptoms of depression, suicidal ideation, or psychosis, and
cases of suicide, have been reported with increased frequency with
patients receiving AVONEX. Severe hepatic injury, including cases
of hepatic failure has been reported rarely in patients. Rare cases
of anaphylaxis have been reported. While beta interferons do not
have any known direct cardiac toxicity, cases of congestive heart
failure, cardiomyopathy, and cardiomyopathy with congestive heart
failure have been reported in patients without known
predisposition. Decreased peripheral blood counts have been
reported from postmarketing experience. Seizures have been reported
in patients using AVONEX, including patients with no prior history
of seizure. Autoimmune disorders of multiple target organs have
been reported. Routine periodic blood chemistry, hematology, liver
function, and thyroid function tests are recommended. There are no
adequate and well-controlled studies in pregnant women. AVONEX
should be used during pregnancy only if the potential benefit
justifies the potential risk to the fetus. The most common side
effects associated with AVONEX treatment are flu-like symptoms,
including chills, fever, myalgia, and asthenia.
Please click here for Important Safety
Information and full Prescribing Information,
including Medication Guide for AVONEX in the U.S., or visit
your respective country’s product website.
About Biogen At Biogen, our mission is clear:
we are pioneers in neuroscience. Biogen discovers, develops, and
delivers worldwide innovative therapies for people living with
serious neurological and neurodegenerative diseases as well as
related therapeutic adjacencies. One of the world’s first global
biotechnology companies, Biogen was founded in 1978 by Charles
Weissmann, Heinz Schaller, Kenneth Murray, and Nobel Prize winners
Walter Gilbert and Phillip Sharp, and today has the leading
portfolio of medicines to treat multiple sclerosis, has introduced
the first approved treatment for spinal muscular atrophy,
commercializes biosimilars of advanced biologics, and is focused on
advancing research programs in multiple sclerosis and
neuroimmunology, neuromuscular disorders, movement disorders,
Alzheimer’s disease and dementia, ophthalmology, immunology,
neurocognitive disorders, acute neurology, and pain.
We routinely post information that may be important to investors
on our website at www.biogen.com. To learn more, please
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Biogen Safe Harbor This news release contains
forward-looking statements, including statements made pursuant to
the safe harbor provisions of the Private Securities Litigation
Reform Act of 1995, relating to the potential benefits, safety and
efficacy of TYSABRI, PLEGRIDY and AVONEX; potential clinical
effects of TYSABRI, PLEGRIDY and AVONEX; the results of certain
real-world data; the clinical development program for natalizumab;
clinical trial results and plans; our research and development
program for the treatment of MS; the treatment of MS; the potential
of our commercial business; and risks and uncertainties associated
with drug development and commercialization. These forward-looking
statements may be identified by words such as “aim,” “anticipate,”
“believe,” “could,” “estimate,” “except,” “forecast,” “goal,”
“intend,” “may,” “plan,” “possible,” “potential,” “will,” “would”
and other words and terms of similar meaning. 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. Results in early stage clinical
trials may not be indicative of full results or results from later
stage or larger scale clinical trials and do not ensure regulatory
approval. You should not place undue reliance on these statements
or the scientific data presented.
These statements involve risks and uncertainties that could
cause actual results to differ materially from those reflected in
such statements, including without limitation the occurrence of
adverse safety events and/or unexpected concerns that may arise
from additional data or analysis; risks of unexpected costs or
delays; regulatory authorities may require additional information
or further studies, or may fail to approve or may delay approval of
our products and expansion of product labeling; unexpected concerns
may arise from additional data, analysis or results obtained during
our clinical trials; failure to protect and enforce our data,
intellectual property and other proprietary rights and
uncertainties relating to intellectual property claims and
challenges; and product liability claims. The foregoing sets forth
many, but not all, of the factors that could cause actual results
to differ from our expectations in any forward-looking statement.
Investors should consider this cautionary statement, as well as the
risk factors identified in our most recent annual or quarterly
report and in other reports we have filed with the U.S. Securities
and Exchange Commission. These statements are based on our current
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forward-looking statements, whether as a result of new information,
future developments or otherwise.
MEDIA CONTACT:David
Caouette +1 617 679 4945public.affairs@biogen.com |
INVESTOR CONTACT:Joe Mara+1 781
464 2442 IR@biogen.com |
1 Combined post-marketing data based on prescriptions and
clinical trials exposure to TYSABRI as of June 30, 20192 Salvetti
et al. ECTRIMS 2019, P1019.3 Benedict et al. ECTRIMS 2019,
P420.
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