New Data at AAN 2022 Highlight Real-World Evidence from Biogen’s MS
Portfolio and Emerging Research on Disease Progression
Biogen Inc. (Nasdaq: BIIB) today announced new data from its
industry-leading portfolio of multiple sclerosis (MS) therapies
being presented at the American Academy of Neurology (AAN) 2022
Annual Meeting. The presentations include new real-world, long-term
data on TYSABRI® (natalizumab), as well as persistence and
adherence learnings with VUMERITY® (diroximel fumarate). Additional
presentations highlight the use of digital tools to potentially
predict MS disease progression. These data build on ongoing work to
advance the understanding and treatment of serious neurological and
neurodegenerative diseases, and highlight Biogen’s commitment to
science that strives to address the diverse needs of people living
with MS.
“Through our close work with the MS community, we have gained a
strong appreciation for the diverse needs of people living with MS
and continue to pursue research that is important to patients,
including these new data on TYSABRI and VUMERITY,” said Maha
Radhakrishnan, M.D., Chief Medical Officer at Biogen. “Additional
presentations at AAN demonstrate our focus on advancing
neuroscience research, including the ambitious work underway
through Biogen Digital Health to identify digital health solutions
aimed at improving the diagnosis and treatment of neurological
conditions.”
Real-World and Clinical Trial Data Show Consistent
Profile With Long-Term TYSABRI Use and Every-Six Week
AdministrationTwo presentations contribute to the
understanding of extended interval dosing (EID) with intravenous
(IV) natalizumab in real-world and clinical trial settings.
- An updated analysis of the U.S. TOUCH® (TYSABRI Outreach:
Unified Commitment to Health) database as of June 30, 2021,
confirms results from earlier analyses, which found that EID with
IV administration of natalizumab is associated with a significantly
lower risk of progressive multifocal leukoencephalopathy (PML) than
the approved every four-week (Q4W) dosing. In the updated analysis,
which included more patients and longer exposures, EID was
associated with a significant 87% reduction (hazard ratio 0.127;
P<0.0001) in the probability of PML in comparison to the
approved Q4W dose.
- Primary results from the Phase 3b NOVA study of every six-week
(Q6W) IV dosing with natalizumab were also presented during a
platform session, showing that Q6W administration of natalizumab
maintains control of MS disease activity in patients who switched
to Q6W after at least one year of disease stability on the approved
Q4W IV dosing schedule. Topline data were first reported in August
2021, and additional results were shared at the European Committee
for Treatment and Research in Multiple Sclerosis (ECTRIMS) annual
congress last year. The approved dose of TYSABRI is 300mg on a Q4W
dosing regimen.
In addition to the data presented on Q6W IV dosing with
natalizumab, a new analysis of the observational STRIVE study using
the approved Q4W IV TYSABRI dosing schedule found that
treatment-naïve patients with early relapsing-remitting multiple
sclerosis (RRMS) had improved clinical outcomes in comparison with
patients who had received prior disease-modifying therapies (DMTs).
These findings provide useful information on the added clinical
benefit that initiating treatment early in the disease course with
TYSABRI may provide. At four years, the cumulative probability of
24-week confirmed disability worsening (CDW) was significantly
lower in treatment-naïve patients than in patients with prior DMT
treatment (11.5% vs 29.0%; P=0.0015).
Real-World Analyses Further Demonstrate High Rates of
Persistence and Adherence for VUMERITYIn the treatment of
MS, high levels of adherence and persistence with DMTs are
associated with improved clinical outcomes and reduced treatment
costs.1 Two claims analyses from AcariaHealth Specialty Pharmacy
Program and Optum showed high rates of persistence and adherence
with VUMERITY, consistent with clinical trial experience and
further supporting VUMERITY as a well-tolerated oral fumarate
option due to its gastrointestinal (GI) tolerability profile.
- A retrospective analysis of the AcariaHealth Specialty Pharmacy
Program included 1,143 patients who initiated therapy with VUMERITY
between Dec. 1, 2019, and Jan. 30, 2021. Persistence as measured by
the overall estimated proportion of patients remaining on VUMERITY
at 16 months was 82.3%; 4.5% discontinued VUMERITY due to GI side
effects. Adherence, as measured by proportion of days covered
(PDC), was 90.8%, and 85.4% of patients achieved a PDC ≥80%.
Consistent findings were also observed in a subgroup of 433
patients who switched from TECFIDERA® (dimethyl fumarate) to
VUMERITY.
- An Optum claims analysis included 1,885 patients with at least
one MS-related claim between Oct. 1, 2019, and March 31, 2021: 224
were treated with VUMERITY, 746 with TECFIDERA, 601 with
teriflunomide, 182 with fingolimod and 132 with siponimod.
Persistence and adherence rates for VUMERITY after 90 days were 84%
and 88%, respectively, consistent with or higher than those for
other DMTs; 79% of patients achieved a PDC ≥80%.
Biogen Continues Pursuit of Innovation in MS With
Digital Health ResearchMultiple presentations support
Biogen’s commitment to delivering innovative approaches to reframe
the care and treatment of MS, including the development of digital
tools to help refine the assessment of disease progression by using
cutting-edge computer vision applied to brain magnetic resonance
imaging (MRI) scans. Several abstracts highlight early work using
machine learning to predict MS lesion formation and detect slowly
expanding lesions (SELs). This research is designed to help better
understand MS disease heterogeneity by unravelling the mechanisms
of acute lesion formation and chronic lesion evolution, which could
in the future help inform clinical trial design and, ultimately,
improve patient care.
“This is an exciting time in MS research as we see the
confluence of medical and computational science,” said Shibeshih
Belachew, M.D. PhD., Head of Science, Biogen Digital Health. “These
presentations on novel medical image computing tools and advanced
algorithmic solutions provide an early vision for predicting
disease progression, driving even greater steps toward more precise
and personalized care of people living with MS.”
Data Presentations Featured at AAN:
- Natalizumab Extended Interval Dosing (EID) Is Associated with a
Reduced Risk of Progressive Multifocal Leukoencephalopathy (PML)
Compared with Every-4-Week (Q4W) Dosing: Updated Analysis of the
TOUCH® Prescribing Program Database – P13.010 – Wednesday, April 6,
8-9 a.m. PDT
- Primary Results of NOVA: a Randomized Controlled Study of the
Efficacy of 6-Week Dosing of Natalizumab Versus Continued 4-Week
Treatment for Multiple Sclerosis – S14.005 – Monday, April 4,
4:18-4:30 p.m. PDT
- Effectiveness of Natalizumab Treatment in Patients with Early
Relapsing-Remitting Multiple Sclerosis (RRMS) Who Were
Treatment-Naive Versus Those Who Had Prior Disease-Modifying
Therapy (DMT) Use – P6.006 - Sunday, April 3, 5:30-6:30 p.m.
PDT
- Updated Real-World Analysis Affirms the High Persistence and
Adherence Observed with Diroximel Fumarate in Patients with
Multiple Sclerosis – P9.007 – Monday, April 4, 5:30-6:30 p.m.
PDT
- Diroximel Fumarate (DRF) Has High Rates of Real-World Adherence
and Persistence in Patients with Multiple Sclerosis (MS):
Retrospective Claims Analysis – P9.008 – Monday, April 4, 5:30-6:30
p.m. PDT
- Diroximel Fumarate in Patients with Relapsing-Remitting
Multiple Sclerosis: Interim Safety and Efficacy Results from the
Phase 3 EVOLVE-MS-1 Study – P7.008 – Monday, April 4, 8-9 a.m.
PDT
- Machine Learning-Based Detection of Slowly Expanding Lesions
Using Radiomic Features from Cross-sectional Brain MRI – S26.004 –
Wednesday, April 6, 1:36-1:48 p.m. PDT
- Machine Learning-Based Prediction of New Multiple Sclerosis
Lesion Formation Using Radiomic Features from Pre-Lesion Normal
Appearing White Matter – S26.009 – Wednesday, April 6,
2:36-2:48 p.m. PDT
- Exploring the Utility of MRI-Based
‘SuStaIn’ Disease Subtyping for Precision Medicine in Relapsing and
Secondary Progressive MS – P15.002 – Wednesday, April 6 at
5:30-6:30 p.m. PDT
About TYSABRI®
(natalizumab) TYSABRI is a well-established
relapsing multiple sclerosis (RMS) treatment indicated for
relapsing forms of MS in adults 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 240,000 people worldwide have
been treated with TYSABRI, with over 970,000 patient-years of
experience, based on clinical trials and prescription data.2
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. When
initiating and continuing treatment with TYSABRI, physicians should
consider whether the expected benefit of TYSABRI is sufficient to
offset this risk.
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), a decrease in lymphocyte counts 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
VUMERITY® (diroximel
fumarate)VUMERITY is an oral fumarate with a distinct
chemical structure from TECFIDERA® (dimethyl fumarate), approved in
the U.S. for the treatment of relapsing forms of multiple sclerosis
in adults, to include clinically isolated syndrome,
relapsing-remitting disease and active secondary progressive
disease. Once in the body, VUMERITY rapidly converts to monomethyl
fumarate, the same active metabolite of dimethyl fumarate. VUMERITY
is approved in more than 30 countries, and more than 20,000
patients have been treated with it, representing more than 15,000
patient-years of exposure across clinical trial use and patients
prescribed VUMERITY. 3
VUMERITY is contraindicated in patients with known
hypersensitivity to diroximel fumarate, dimethyl fumarate or to any
of the excipients of VUMERITY; and in patients taking dimethyl
fumarate. Serious side effects for VUMERITY are based on data from
dimethyl fumarate (which has the same active metabolite as
VUMERITY) and include anaphylaxis and angioedema, progressive
multifocal leukoencephalopathy, which is a rare opportunistic viral
infection of the brain that has been associated with death or
severe disability, a decrease in mean lymphocyte counts during the
first year of treatment, herpes zoster and other serious
infections, liver injury and flushing. The most common adverse
events, obtained using data from dimethyl fumarate (which has the
same active metabolite as VUMERITY), were flushing, abdominal pain,
diarrhea and nausea.
Please click here for Important Safety
Information and full Prescribing Information,
including Patient Information for VUMERITY in the
U.S.
About
TECFIDERA® (dimethyl
fumarate) TECFIDERA, a treatment for relapsing forms
of multiple sclerosis (MS) in adults, is the most prescribed oral
medication for relapsing MS in the world and has been shown to
reduce the rate of MS relapses, slow the progression of disability
and impact the number of MS brain lesions, while demonstrating a
well-characterized safety profile in people with relapsing forms of
MS. TECFIDERA is approved in 69 countries, and more than
560,000 patients have been treated with it, representing more than
1,100,000 patient-years of exposure across clinical trial use and
patients prescribed TECFIDERA.4
TECFIDERA is contraindicated in patients with a known
hypersensitivity to dimethyl fumarate or any of the excipients of
TECFIDERA. Serious side effects include anaphylaxis and angioedema,
and cases of progressive multifocal leukoencephalopathy, a rare
opportunistic viral infection of the brain which has been
associated with death or severe disability, have been seen with
TECFIDERA patients in the setting of prolonged lymphopenia although
the role of lymphopenia in these cases is uncertain. Other serious
side effects include a decrease in mean lymphocyte counts during
the first year of treatment, herpes zoster and other serious
infections, liver injury and flushing. In clinical trials, the most
common adverse events associated with TECFIDERA were flushing,
abdominal pain, diarrhea and nausea.
Please click here for Important Safety
Information and full Prescribing Information,
including Patient Information for TECFIDERA in the U.S.,
or visit your respective country’s product website.
About BiogenAs pioneers in neuroscience, Biogen
discovers, develops, and delivers worldwide innovative therapies
for people living with serious neurological 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, Sir Kenneth Murray, and Nobel Prize
winners Walter Gilbert and Phillip Sharp. Today, Biogen has a
leading portfolio of medicines to treat multiple sclerosis, has
introduced the first approved treatment for spinal muscular
atrophy, and is providing the first and only approved treatment to
address a defining pathology of Alzheimer’s disease. Biogen is also
commercializing biosimilars and focusing on advancing the
industry’s most diversified pipeline in neuroscience that will
transform the standard of care for patients in several areas of
high unmet need.
In 2020, Biogen launched a bold 20-year, $250 million initiative
to address the deeply interrelated issues of climate, health, and
equity. Healthy Climate, Healthy Lives™ aims to eliminate fossil
fuels across the company’s operations, build collaborations with
renowned institutions to advance the science to improve human
health outcomes, and support underserved communities.
The company routinely posts information that may be important to
investors on our website at www.biogen.com. To learn more,
please visit www.biogen.com and follow Biogen on social
media
– Twitter, LinkedIn, Facebook, YouTube.
Biogen Safe HarborThis 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 and VUMERITY; the results of certain real-world
data; clinical trials and data readouts and presentations; the
identification and treatment of MS; our research and development
program for the treatment of MS; the potential benefits of digital
health technologies; and the potential of our commercial business,
including TYSABRI and VUMERITY. These forward-looking statements
may be identified by words such as “aim,” “anticipate,” “believe,”
“could,” “estimate,” “expect,” “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. 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; failure to protect and enforce our data, intellectual
property and other proprietary rights and uncertainties relating to
intellectual property claims and challenges; product liability
claims; third party collaboration risks; and the direct and
indirect impacts of the ongoing COVID-19 pandemic on our business,
results of operations and financial condition. 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 beliefs and expectations and speak only as of the date
of this news release. We do not undertake any obligation to
publicly update any forward-looking statements, whether as a result
of new information, future developments or otherwise.
References:
- Lizán L, et al. Patient Prefer Adherence.
2014;8:1653-1664.
- Combined post-marketing data based on prescriptions and
clinical trials exposure to TYSABRI as of January 31, 2022.
- Combined post-marketing data based on prescriptions and
clinical trials exposure to VUMERITY as of December 31, 2021
- Combined post-marketing data based on prescriptions and
clinical trials exposure to TECFIDERA as of December 31, 2021.
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MEDIA CONTACT:Ashleigh Koss+ 1 908 205
2572public.affairs@biogen.com |
INVESTOR CONTACT:Mike Hencke+1 781 464
2442IR@biogen.com |
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