Biogen Announces FDA Approval of PLEGRIDY® (peginterferon beta-1a)
Intramuscular Administration for Multiple Sclerosis
Biogen Inc. (Nasdaq: BIIB) today announced that the U.S. Food
and Drug Administration (FDA) has approved a new intramuscular (IM)
injection route of administration for PLEGRIDY® (peginterferon
beta-1a) for the treatment of relapsing forms of multiple sclerosis
(MS). The new IM administration offers people living with relapsing
MS the well-characterized efficacy and safety of PLEGRIDY with the
potential for significantly reduced injection site reactions. This
approval expands Biogen’s industry-leading portfolio of MS
treatments, which also includes the subcutaneous (SC)
administration of PLEGRIDY, and follows the European Commission’s
marketing authorization for the IM administration in December 2020.
“At Biogen, we are committed to continued
innovation to give people with MS more choices and more options to
meet their individual preferences and needs,” said Maha
Radhakrishnan, M.D., Chief Medical Officer at Biogen. “PLEGRIDY is
a proven, effective therapy for relapsing MS, and this approval
gives new and current MS patients a different delivery method that
has the potential to significantly reduce injection site
reactions.”
MS is an autoimmune disorder that affects more than
2.3 million people worldwide. Access to and availability of
treatment options have become increasingly important in the current
COVID-19 environment. The addition of the IM administration of
PLEGRIDY to Biogen’s MS portfolio offers another important option
at a time when MS patients are being encouraged to discuss their MS
treatment and considerations around COVID-19 vaccination with their
physicians.1,2
The FDA’s approval of the IM administration for
PLEGRIDY is based on data evaluating bioequivalence and adverse
reactions associated with IM administration compared to SC
administration in healthy volunteers. Bioequivalence between the
two dosing regimens was confirmed and data show that participants
receiving PLEGRIDY through IM administration experienced fewer
injection site reactions in comparison to participants receiving SC
administration (14.4 percent vs. 32.1 percent). The overall safety
profiles were generally similar and there were no new safety
signals observed.3
PLEGRIDY is the only approved pegylated interferon
for MS with a proven ability to delay the progression of MS
disability and reduce relapses. PLEGRIDY was first approved by the
FDA in 2014 and is proven to significantly reduce MS relapses,
disability progression and brain lesions with a well-understood
safety and tolerability profile. It is available in more than 60
countries.
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.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; 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
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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 PLEGRIDY; and the results of
certain real-world data. 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; 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; 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:1 National Multiple
Sclerosis Society. COVID-19 Guidance for People Living with MS.
Available at:
https://www.nationalmssociety.org/coronavirus-covid-19-information/multiple-sclerosis-and-coronavirus/covid-19-vaccine-guidance.
Accessed: January 2021.2 Multiple Sclerosis
International Federation. MS, the coronavirus and
vaccines – updated global advice.. Available at:
https://www.msif.org/news/2020/02/10/the-coronavirus-and-ms-what-you-need-to-know/.
Accessed: January 2021.3 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. 4 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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