Biogen Inc. (Nasdaq: BIIB) today announced that the Committee
for Medicinal Products for Human Use (CHMP), part of the European
Medicines Agency (EMA), issued a positive opinion and has
recommended granting marketing authorization for
VUMERITY® (diroximel fumarate) in the European Union (EU).
VUMERITY is a next-generation oral fumarate for the treatment of
adults with relapsing-remitting multiple sclerosis (RRMS). An
estimated 2.8 million people live with MS across the globe, with
some European countries demonstrating the highest prevalence of MS
in the world.1
“With MS, finding the right treatment option is as much about
managing the clinical aspects of the disease as it is about how
treatment fits into a person’s life,” said Simon Faissner, M.D.,
PhD, Assistant Professor at the Department of Neurology,
Ruhr-University Bochum. “Today’s CHMP opinion is a crucial step
forward in providing an oral therapeutic option that is easy to
integrate into a patient’s daily life, which helps with ongoing
care management.”
The CHMP’s positive opinion will now be referred to the European
Commission (EC), which grants marketing authorizations for
medicines in Europe.
“We look forward to advancing Biogen’s portfolio and continuing
to work with the MS community to address critical treatment
challenges, including those that affect persistence and adherence
to medication for this chronic and life-long disease,” said Alfred
Sandrock, Jr., M.D., Ph.D., Head of Research and Development at
Biogen. “VUMERITY builds on our experience in MS and the
established profile of TECFIDERA to bring a new oral option at a
time when people with MS are making treatment decisions while
considering other factors related to their ongoing care during the
pandemic.”
The positive CHMP opinion was based on data from pharmacokinetic
bridging studies comparing VUMERITY and TECFIDERA® (dimethyl
fumarate) to establish bioequivalent exposure of monomethyl
fumarate, the active metabolite, and relied in part on the
well-established long-term safety and efficacy profile of
TECFIDERA. The CHMP also assessed 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 RRMS. 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.
VUMERITY was first approved by the U.S. Food and Drug
Administration in October 2019 and is currently the number one
prescribed oral MS therapy in the country. 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.2 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.
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
1,000,000 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.3
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 lymphopenia. 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 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
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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 potential benefits,
safety and efficacy of TECFIDERA; the results of certain real-world
data; and the potential of Biogen’s commercial business, including
VUMERITY and TECFIDERA. 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,
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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
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of this news release. We do not undertake any obligation to
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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/.
- 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
December 31, 2020.
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