The European Commission Grants Marketing Authorization for
VUMERITY® (diroximel fumarate) as Oral Treatment for
Relapsing-Remitting Multiple Sclerosis
Biogen Inc. (Nasdaq: BIIB) today announced that the European
Commission (EC) has granted marketing authorization for VUMERITY®
(diroximel fumarate) to treat adults with relapsing-remitting
multiple sclerosis (MS). VUMERITY is a next-generation fumarate
that offers the convenience of an oral medication with the
established efficacy and well-characterized safety of TECFIDERA®
(dimethyl fumarate). Globally, an estimated 2.8 million people live
with MS, with more than 1 million people in Europe living with the
disease.1,2
“The approval of VUMERITY provides a new oral treatment option
with low gastrointestinal discontinuation rates that may help
patients to start and adhere to treatment,” said Simon Faissner,
M.D., PhD, Assistant Professor at the Department of Neurology,
Ruhr-University Bochum. “This medication allows for MS patients in
the EU to be treated without having to think about dietary
restrictions or when to take a dose in relation to mealtimes which,
when treating a chronic disease, may provide patients with
additional flexibility in their daily lives.”
The EC’s approval of VUMERITY is based on data from
pharmacokinetic bridging studies comparing VUMERITY and TECFIDERA
to establish bioequivalent exposure of monomethyl fumarate, the
active metabolite, and relied in part on the well-established
long-term efficacy and safety profile of TECFIDERA. The approval
was also based on findings from EVOLVE-MS-2, a large, randomized,
double-blind, five-week, multi-center Phase 3 study to evaluate the
gastrointestinal (GI) tolerability of VUMERITY compared to
TECFIDERA in patients with relapsing-remitting MS. In EVOLVE-MS-2,
the rate of overall treatment discontinuation was lower in
participants treated with VUMERITY compared to those treated with
TECFIDERA (1.6% compared to 6%, respectively). The difference in
the discontinuation rates due to GI tolerability was 0.8% for
VUMERITY compared to 4.8% for TECFIDERA. Additionally, flushing was
reported in 32.8% of VUMERITY-treated patients and in 40.6% of
TECFIDERA treated patients. There were no serious events of
flushing or discontinuations due to flushing in the study.
“This approval is a significant step forward in improving
treatment adherence for people living with relapsing MS, which can
make a meaningful difference on treatment outcomes impacting their
daily lives,” said Maha Radhakrishnan, M.D., Chief Medical Officer
at Biogen. “The authorization of VUMERITY in the EU brings people
with MS a new oral treatment option to meet their individual
preferences and needs, with well-established efficacy and a
positive GI tolerability profile that continues to be evaluated in
the real-world setting.”
VUMERITY was first approved by the U.S. Food and Drug
Administration in October 2019 and is also approved in Great
Britain and Switzerland. Since its launch in the U.S., real-world
data have reinforced the positive GI tolerability profile of
VUMERITY and confirmed that the experience demonstrated in clinical
trials is consistent with clinical practice.3 Biogen continues
to file regulatory submissions in other countries.
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 providing similar efficacy and safety profiles.
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.,
or visit your respective country’s product website.
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 530,000
patients have been treated with it, representing more than
1,000,000 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.
For information on TECFIDERA prescribing information in the EU,
please visit:
https://www.ema.europa.eu/en/medicines/human/EPAR/tecfidera. 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 the
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 its 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, about potential regulatory discussions,
submissions and approvals and the timing thereof; the potential
benefits, safety and efficacy of VUMERITY; the results of certain
real-world data; and the potential of Biogen’s commercial business,
including 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. 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 actual timing and
content of submissions to and decisions made by the regulatory
authorities; regulatory submissions may take longer or be more
difficult to complete than expected; regulatory authorities may
require additional information or further studies, or may fail or
refuse to approve or may delay approval of our drug candidates or
expansion of product labeling; failure to obtain regulatory
approvals in other jurisdictions; the occurrence of adverse safety
events; 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; 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:
- Walton, Clare.
“Rising Prevalence of Multiple SCLEROSIS Worldwide: Insights from
the Atlas of Ms, Third Edition.” Multiple Sclerosis (Houndmills,
Basingstoke, England), U.S. National Library of Medicine, 11 Nov.
2020, pubmed.ncbi.nlm.nih.gov/33174475/.
- “EMSP - Barometer.”
MS Barometer, European Multiple Sclerosis Platform, 20 Dec. 2020,
https://msbarometer.eu/2020.
- Liseno J, et al. Multiple Sclerosis
Patients Treated with Diroximel Fumarate in the Real-World Setting
have High Rates of Persistence and Adherence. Neurology. April 13,
2021; 96 (15 Supplement).
- Combined post-marketing data based
on prescriptions and clinical trials exposure to TECFIDERA as of
June 30, 2021.
MEDIA CONTACT:BiogenAshleigh Koss+ 1 908 205
2572public.affairs@biogen.com |
INVESTOR CONTACT:BiogenMike Hencke+1 781 464
2442IR@biogen.com |
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