Biogen Grows Presence in China with the Approval of TECFIDERA®
(dimethyl fumarate) for the Treatment of Relapsing Multiple
Sclerosis
Biogen Inc. (Nasdaq: BIIB) today announced that China’s National
Medical Products Administration (NMPA) has approved TECFIDERA®
(dimethyl fumarate) for the treatment of relapsing multiple
sclerosis (MS). First introduced in 2013, TECFIDERA has
demonstrated a well-established safety and efficacy profile with
more than 10 years of data from clinical trials and real-world
experience.1 It has been used to treat more than 500,000
individuals with MS worldwide.1 The approval brings a new treatment
option to people in China living with relapsing MS and also
continues to expand the company’s presence in the country.
“It is truly a milestone to bring this well-established
treatment to China and be able to help people living with relapsing
multiple sclerosis,” said Rachid Izzar, President, Intercontinental
Region at Biogen. “We thank the NMPA for undertaking priority
review to approve TECFIDERA. We are committed to expanding our
presence in China and working with the MS community to address
unmet medical needs through innovative therapies and
solutions.”
The NMPA evaluation was based on data from the global, pivotal
Phase 3 DEFINE and CONFIRM studies, which enrolled more than 2,600
patients. In DEFINE, TECFIDERA administered twice daily
significantly reduced the annualized relapse rate by 53 percent
(p<0.0001) compared to placebo, at two years. In CONFIRM,
twice-daily TECFIDERA significantly reduced the proportion of
patients who relapsed by 34 percent (p=0.0020) compared to placebo
at two years.
“MS is an inflammatory disease that attacks the central nervous
system and, if not treated in a timely manner and following
standard protocol, can lead to disability due to irreversible
neurological damage. Currently in China, a small number of patients
are treated according to the standard of care with a disease
modifying therapy,” said Professor Yongjun Wang, deputy director of
the National Clinical Research Center for Neurological Diseases,
chairman of the Chinese Society of Neurology and president and
chief physician of Beijing Tiantan Hospital, Capital Medical
University. “The characteristics, clinical manifestation and
disease course varies greatly among patients, which makes
personalized treatment essential. Results from clinical trials and
more than a decade of real-world evidence have demonstrated the
efficacy, safety and tolerability of dimethyl fumarate. The
approval and availability of dimethyl fumarate will provide a new
option for patients and will help contribute to the clinical
evidence on treating MS in China.”
The December 2020 General Social Survey on Patients with
Multiple Sclerosis in China by the China Alliance for Rare Diseases
found that among people with MS who are unemployed or out of
school, 90 percent was due to their diagnosis. The report notes the
need for the community to work together to help patients and
families address the physical and mental challenges that can result
from MS.
MS is a life-long, progressive, autoimmune neurologic disease of
the central nervous system (CNS). In China, only approximately 10
percent of the population diagnosed with MS is being treated with a
disease modifying treatment.2 It is the second most common
cause of non-traumatic neurological disability in young
adults.3 The disease causes damage to the CNS resulting in
physical disability as well as neurological dysfunctions involving
movement, vision and cognition. The severity and specific symptoms
of MS vary from person to person. More than 85 percent of people
with MS are diagnosed with relapsing MS, the most common form of
the disease.
In May 2018 MS was included on China’s First National List
of Rare Diseases, which was jointly developed by five national
bodies to support diagnosis and treatment of rare conditions. The
NMPA initiated a priority review process to evaluate innovative
treatments using clinical evidence from trials conducted in major
independent review markets. In November 2020 TECFIDERA was included
in the list of the Third Batch of New Overseas Drugs Urgently
Needed in Clinical Settings by the Center for Drug Evaluation under
the NMPA.
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 including clinically isolated syndrome, relapsing-remitting
disease and active secondary disease. 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.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 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 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, relating to the potential benefits, safety and
efficacy of TECFIDERA; the results of certain real-world data;
results from the Phase 3 DEFINE study and the Phase 3 CONFIRM
study; the identification and treatment of MS; our research and
development program for the treatment of MS; and the potential of
Biogen’s commercial business, including 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. 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; 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; 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; 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.
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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 TECFIDERA as of December 31, 2020.
- Chinese Society of Neurology, Chinese Medical Association;
China International Exchange and Promotive Association for Medical
and Healthcare (2018). China vsMS Report (China MS Patient Status
Report).
- Dimitrov L.G. and Turner B. The British journal of general
practice: the journal of the Royal College of General Practitioners
volume 64 issue 629 pages 612-613 December 2014.
MEDIA CONTACT:David Caouette+ 1 617 679
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INVESTOR CONTACT:Mike Hencke+1 781 464 2442IR@biogen.com |
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