New Data at AAN Showcase Biogen’s Commitment to Advancing
Innovation in MS
Biogen Inc. (Nasdaq: BIIB) today announced new data from its
robust multiple sclerosis (MS) treatment portfolio. Additional
clinical data support VUMERITY® (diroximel fumarate) as an
important oral treatment option in relapsing MS and reinforce the
efficacy of TECFIDERA® (dimethyl fumarate). In addition, an
analysis of TYSABRI® (natalizumab) contributes to data
demonstrating the reduced risk of progressive multifocal
leukoencephalopathy (PML) through extended interval dosing (EID;
approximately every six weeks) as compared to the currently
approved dosing of every four weeks. These new data were selected
for presentation at the 72nd American Academy of Neurology (AAN)
annual meeting and will be available online via the 2020 AAN
Science Highlights virtual platform.
“We continue to lead in MS with new data that demonstrate the
strength of our portfolio and Biogen’s commitment to enhancing the
care of individuals with relapsing MS,” said Bernd Kieseier, M.D.,
MHBA, Executive Director, Head of Global MS, Worldwide Medical,
Biogen. “The data shared at AAN represent our ongoing efforts to
improve the MS treatment experience and deliver therapies that
provide clinically meaningful benefits to individuals living with
this chronic disease.”
Data Demonstrate Early Efficacy of TECFIDERA and
VUMERITY In an analysis of data from the double-blind,
randomized, Phase 3 EVOLVE-MS-2 study, patients treated with
VUMERITY or TECFIDERA (n=295) demonstrated a significant reduction
in gadolinium-enhancing (Gd+) lesion counts as early as seven weeks
after treatment initiation. After continuing treatment with
VUMERITY in the ongoing, open-label, Phase 3 EVOLVE-MS-1 study
(n=82), researchers observed that 96.3 percent of patients were
free from Gd+ lesions after one year. Both TECFIDERA and VUMERITY
have shown early and sustained efficacy in patients with
relapsing-remitting MS (RRMS).
Improved Patient-reported GI Tolerability with
VUMERITY A separate, exploratory analysis of EVOLVE-MS-2
(n=502) data assessed the impact of gastrointestinal (GI) symptoms
as reported by RRMS patients and expands understanding of
VUMERITY’s GI tolerability. GI events including nausea, vomiting,
upper and lower abdominal pain and diarrhea were less likely to be
disruptive to daily activities for VUMERITY-treated patients.
Additionally, patients taking VUMERITY were less likely than
patients on TECFIDERA to score 2 or higher—the primary endpoint—for
two or more consecutive days on the Individual Gastrointestinal
Symptom and Impact Scale (IGISIS) (17.4 percent vs. 29.3 percent),
and fewer reported concomitant medications for GI tolerability (19
percent vs. 31 percent).
Real-world Evidence Advances Natalizumab-associated
Research A real-world analysis (n=139) of RRMS patients
who switched from the approved every-four-week (Q4W) dosing to
natalizumab EID (approximately every six weeks) did not show
differences in serum neurofilament light (sNfL) levels from those
patients who remained on Q4W dosing. sNfL is emerging as a
potential biomarker of MS disease activity. These findings support
previous reports that EID may not be associated with increased
disease activity and suggest the longer treatment interval may not
compromise efficacy.
Additionally, updated analyses of real-world data from the
TOUCH® Prescribing Program Database continue to demonstrate
natalizumab EID is associated with a lower risk for PML than the
approved Q4W dosing in anti-JC virus antibody positive patients.
The most recent analysis is consistent with previous findings.
Biogen continues to evaluate the efficacy of EID in NOVA
(NCT03689972), a two-year, prospective, randomized, interventional,
controlled, open-label, rater-blinded, international Phase 3b study
assessing the efficacy, safety and tolerability of six-week
natalizumab dosing intervals in people with RRMS.
Continued Efforts to Evaluate the Treatment Experience
for People Living With MS In addition to the presented
data, Biogen recently submitted regulatory filings in the U.S. and
the European Union for intramuscular (IM) injection of PLEGRIDY®
(peginterferon beta-1a). PLEGRIDY is currently approved to be
administered by subcutaneous injection and is available in more
than 60 countries. Previously presented data have evaluated
bioequivalence and adverse reactions after IM dosing compared to
subcutaneous injection.1 In addition, earlier this year, the U.S.
Food and Drug Administration updated the prescribing information
for PLEGRIDY and AVONEX® (interferon beta-1a) to include additional
information on the use of these therapies during pregnancy and
breastfeeding in women with relapsing MS.
Data Presentations Featured at AAN:
- Diroximel Fumarate and Dimethyl Fumarate Demonstrate Early
Clinical and Radiological Efficacy in Relapsing-Remitting Multiple
Sclerosis
- Improved Gastrointestinal Tolerability Profile With Diroximel
Fumarate Compared to Dimethyl Fumarate in Relapsing MS
Patients
- Serum Neurofilament Light Levels in Patients With
Relapsing-Remitting Multiple Sclerosis Switching From Natalizumab
Every-4-Week Dosing to Extended Interval Dosing
- Updated Incidence of Natalizumab-Associated Progressive
Multifocal Leukoencephalopathy and Its Relationship With
Natalizumab Exposure Over Time
- Natalizumab Extended Interval Dosing Is Associated With a
Reduced Risk of Progressive Multifocal Leukoencephalopathy Than
Every-4-Week Dosing: Updated Analysis of the TOUCH® Prescribing
Program Database
- Interim Analysis of Peginterferon Beta-1a in the Breast Milk of
Lactating Patients With Multiple Sclerosis
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 445,000 patients have been treated with
it, representing more than 875,000 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 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 208,000 people
worldwide have been treated with TYSABRI, with
over 805,000 patient-years of experience, based on
clinical trials and prescription data.3
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) 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® (peginterferon
beta-1a) PLEGRIDY is a subcutaneous 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. Nearly
55,000 people worldwide have been treated with PLEGRIDY, with
over 101,000 patient-years of experience, based on
prescription data.4 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; 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® (interferon
beta-1a) AVONEX is prescribed for relapsing forms of MS
and is currently approved in over 90 countries. Over 570,000 people
worldwide have been treated with AVONEX, with over 2.6
million patient-years of experience, based on prescription data.5
AVONEX is indicated for the treatment of relapsing forms of
multiple sclerosis (MS), to include clinically isolated syndrome,
relapsing-remitting disease, and active secondary progressive
disease, in adults.
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.
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 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, 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 visit
www.biogen.com and follow us on social media – Twitter,
LinkedIn, Facebook, YouTube.
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 VUMERITY, TECFIDERA, TYSABRI and PLEGRIDY; the results
of certain real-world data; results from the EVOLVE-MS-2 study; the
identification and treatment of MS; our research and development
program for the treatment of MS; the potential of Biogen’s
commercial business, including VUMERITY, TECFIDERA, TYSABRI and
PLEGRIDY; 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,” “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. 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; unexpected concerns may arise from additional data,
analysis or results obtained during clinical trials; failure to
protect and enforce our data, intellectual property and other
proprietary rights and uncertainties relating to intellectual
property claims and challenges; 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
product labeling; failure to obtain regulatory approvals in other
jurisdictions; 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.
MEDIA CONTACT:David Caouette+ 1
617 679 4945public.affairs@biogen.com |
INVESTOR CONTACT:Joe Mara+1 781
464 2442IR@biogen.com |
References: 1 Zhao Y, et al. A phase 1, open-label, crossover
study to evaluate the bioequivalence of intramuscular and
subcutaneous peginterferon beta-1a in healthy volunteers. Poster
presented at: Americas Committee for Treatment and Research in
Multiple Sclerosis - 2020 Forum; 2020 Feb 27-29; West Palm Beach,
Florida, USA.2 Combined post-marketing data based on prescriptions
and clinical trials exposure to TECFIDERA as of January 31, 2020. 3
Combined post-marketing data based on prescriptions and clinical
trials exposure to TYSABRI as of February 29, 2020. 4 Combined
post-marketing data based on prescriptions for PLEGRIDY as of
December 31, 2019.5 Combined post-marketing data based on
prescriptions for AVONEX as of December 31, 2019.
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