New Data at AAN 2021 from Across Biogen’s MS Portfolio Demonstrate
Positive Impact of Treatment on People Living with Relapsing
Multiple Sclerosis
Biogen Inc. (Nasdaq: BIIB) today announced new data from its
industry-leading portfolio of multiple sclerosis (MS) therapies to
be presented at the American Academy of Neurology (AAN) 2021
Virtual Annual Meeting, April 17-22. The presentations include data
on quality of life benefits and analyses of extended interval
dosing (EID) with TYSABRI® (natalizumab) as well as new real-world
experience data from VUMERITY® (diroximel fumarate). The research
adds to the vast clinical knowledge Biogen continues to advance as
part of its commitment to the care of people living with MS.
“With chronic conditions like MS, where every patient has a
different experience with the disease, it is critically important
to understand how treatment impacts their daily living and quality
of life,” said Maha Radhakrishnan, M.D., Chief Medical Officer at
Biogen. “These data show that the benefits TYSABRI provides in
terms of a patient’s quality of life are substantial and that the
positive gastrointestinal tolerability profile of VUMERITY can help
people with relapsing MS continue with treatment, which is
essential to delay its progression.”
Analyses Demonstrate Improved Quality of Life Outcomes
with TYSABRI and Further Evaluate Extended
Interval Dosing To better understand clinically meaningful
quality of life benefits following treatment with TYSABRI, MS
PATHS (Partners Advancing Technology and Health Solutions)
researchers analyzed patient reported data on 12 different domains
on the Neuro-QoL (Quality of Life in Neurological Disorders)
questionnaire such as sleep disturbance, anxiety, fatigue,
depression and participation in daily activities. Results
included:
- In people treated with TYSABRI or Ocrevus® (ocrelizumab) with
baseline impairment, statistically significant improvements were
seen in 10 of 12 and 8 of 12 Neuro-QoL domains, respectively. In 11
of 12 domains on the Neuro-QoL questionnaire, the adjusted
annualized rate of improvement was greater with TYSABRI as compared
to Ocrevus.
- The difference between the two therapies was statistically
significant in favor of TYSABRI in three of the domains:
satisfaction with social roles and activities (p=0.02),
participation in social roles and activities (p=0.0001) and
emotional and behavioral dyscontrol (p=0.01).
Neuro-QoL is an independently validated set of patient-reported
outcome measurements that assess the physical, mental and social
effects of people living with neurological conditions such as MS.
Biogen established the MS PATHS network to foster collaboration
between leading MS centers in Europe and the U.S. to help transform
patient care by generating standardized data from a diverse,
real-world patient population.
Additionally, results from two new analyses investigating EID
with natalizumab may help further inform the drug’s benefit-risk
profile. Biogen continues to evaluate the efficacy, safety and
tolerability of natalizumab EID through the prospective NOVA trial
(NCT03689972) with initial results expected in 2021.
- From an analysis of data in MS PATHS, natalizumab patients
receiving either EID or Standard Interval Dosing (SID) had
comparable real-world effectiveness on quantitative magnetic
resonance imaging (MRI) outcomes (p>0.05 for all MRI
outcomes).
- An updated analysis of data from the TOUCH Prescribing Program
demonstrated in the primary analysis that EID is associated with a
significant (P<0.0001) 88% reduction in the risk of progressive
multifocal leukoencephalopathy (PML) in comparison to the approved
every four-week dose. The data, which included more patients
followed for a longer period and with slightly greater exposures,
reinforces results from earlier analyses of EID.
Data Confirm Positive Gastrointestinal Tolerability
Profile With VUMERITY in Real-World SettingNew findings on
the use of VUMERITY in a real-world setting reinforce the benefits
of improved gastrointestinal (GI) tolerability and confirm that the
experience in clinical trials is consistent with clinical practice.
In a retrospective analysis of data from December 2019 to August
2020 of 160 patients with relapsing MS, the treatment
discontinuation rate due to GI side effects was low (3.8%) with
88.6% estimated to still be on therapy at the end of analysis and a
high rate of adherence (91.4%). In a subgroup of patients who
switched from TECFIDERA® (dimethyl fumarate) to VUMERITY, the
majority of patients switched as a result of gastrointestinal
tolerability with most remaining on therapy (92.3%).
Biogen Continues Leading Research in MSThe
presentations at AAN are part of Biogen’s ongoing commitment to the
MS community, improving the understanding of the disease and
advancing treatment through innovation. The company recently
launched a subcutaneous injection of TYSABRI in Europe and an
intramuscular administration of PLEGRIDY® (peginterferon beta-1a)
in the United States and Europe. Biogen currently has more than 25
MS clinical trials underway including research on considerations
around COVID-19 vaccination for people with MS.
Data Presentations Featured at AAN:
- Impact of Natalizumab on Quality of Life in a Real-World Cohort
of Patients with Multiple Sclerosis: Results from MS Partners
Advancing Technology and Health Solutions (MS PATHS) – P15.023
- No Difference in Radiologic Outcomes for Natalizumab Patients
on Extended Interval Dosing Compared with Standard Interval Dosing
in MS PATHS – P15.210
- 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 – P15.201
- Multiple Sclerosis Patients Treated with Diroximel Fumarate in
the Real-world Setting have High Rates of Persistence and Adherence
– P15.227
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 220,000 people worldwide have
been treated with TYSABRI, with over 880,000 patient-years of
experience, based on clinical trials and prescription data.1
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 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
500,000 patients have been treated with it, representing more than
950,000 patient-years of exposure across clinical trial use and
patients prescribed TECFIDERA. Of these, 6,335 patients (14,241
patient-years) were from clinical trials.2
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
PLEGRIDY® (peginterferon
beta-1a)PLEGRIDY is a pegylated interferon dosed once
every two weeks for relapsing forms of multiple sclerosis (MS) in
adults, the most common form of MS. PLEGRIDY is currently approved
in over 60 countries including the U.S., Canada, Australia and
Switzerland and across the European Union. Over 61,000 people
worldwide have been treated with PLEGRIDY, with
over 120,000 patient-years of experience, based on
prescription data.3 Biogen continues to work toward making PLEGRIDY
available in additional countries across the globe.
The efficacy and safety of PLEGRIDY are supported by one of the
largest pivotal studies with interferons conducted in people living
with relapsing-remitting MS. 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 well-characterized 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; injection site reactions, cardiac problems, including
congestive heart failure; blood problems, such as decreases in
white blood cell or platelet counts; autoimmune disorders; 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.
PLEGRIDY can be considered for use in relapsing MS patients
throughout the full course of pregnancy and during breast-feeding,
if clinically needed.
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 BiogenAt 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. Today Biogen 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, Alzheimer’s disease and dementia, neuromuscular
disorders, movement disorders, ophthalmology, neuropsychiatry,
immunology, acute neurology and neuropathic pain.
We routinely post information that may be important to investors
on our website at www.biogen.com. Follow us 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; 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:
- Combined post-marketing data based on prescriptions and
clinical trials exposure to TYSABRI as of January 31, 2021.
- Combined post-marketing data based on prescriptions and
clinical trials exposure to TECFIDERA as of December 31, 2020.
- Combined post-marketing data based
on prescriptions for PLEGRIDY as of September 30, 2020.
MEDIA CONTACT:David Caouette+ 1 617 679
4945public.affairs@biogen.com |
INVESTOR CONTACT:Mike Hencke+1 781 464 2442IR@biogen.com |
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