The European Commission Grants Marketing Authorization for
PLEGRIDY® (peginterferon beta-1a) Intramuscular Administration for
Relapsing-Remitting Multiple Sclerosis
Biogen Inc. (Nasdaq: BIIB) today announced that the European
Commission (EC) has approved a new intramuscular (IM) injection
route of administration for PLEGRIDY® (peginterferon beta-1a) for
the treatment of relapsing-remitting multiple sclerosis (MS). The
new IM administration of PLEGRIDY provides the well-characterized
efficacy and safety of the platform injectable along with the
potential for reduction in injection site reactions. It is
estimated that 2.5 million people live with MS across the globe,
with some European countries demonstrating the highest prevalence
of MS in the world.1 This approval adds to Biogen’s broad MS
portfolio which includes the subcutaneous (SC) injection of
PLEGRIDY and expands the range of treatment options available for
people living with MS.
“The availability of a new intramuscular route of administration
offers individuals living with relapsing MS an additional choice of
a platform therapy, combining the safety and efficacy of PLEGRIDY,
with the potential to significantly reduce injection site
reactions,” said Maha Radhakrishnan, M.D., Chief Medical Officer at
Biogen. “As leaders in MS with our broad portfolio of therapies, we
are focused on advancing the science to address the needs of
patients by providing more treatment choices.”
The EC’s approval of PLEGRIDY for IM administration 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
similar, and the frequency of injection site reactions and adverse
events were comparable in participants who were dosed with IM
followed by SC, compared to SC followed by IM.2
PLEGRIDY, the only pegylated interferon approved for use in
relapsing MS, was first approved in the European Union in 2014 and
is proven to significantly reduce important measures of MS disease
activity with a well-characterized safety and tolerability profile.
Biogen has also submitted a regulatory filing in the U.S. for the
IM administration. The SC administration of PLEGRIDY 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 57,000 people
worldwide have been treated with PLEGRIDY, with
over 107,000 patient-years of experience, based on
prescription data.3 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. PLEGRIDY can be considered for use in MS patients
throughout the full course of pregnancy and during breast-feeding,
if clinically needed.
For information on PLEGRIDY prescribing information in the EU,
please visit:
https://ec.europa.eu/health/documents/community-register/html/h934.htm
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, 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 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; the results of certain real-world data; our
research and development program for the treatment of MS; and
potential regulatory discussions, submissions and approvals and the
timing thereof. 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. 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; 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 Tullman MJ. Overview of the
epidemiology, diagnosis, and disease progression associated with
multiple sclerosis. Am J Manag Care. 2013 Feb;19(2 Suppl): S15-20.
2 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. 3 Combined
post-marketing data based on prescriptions for PLEGRIDY as of March
31, 2020.
MEDIA CONTACT:David Caouette+ 1 617 679
4945public.affairs@biogen.com |
INVESTOR CONTACT:Joe Mara+1 781 464 2442IR@biogen.com |
Biogen (TG:IDP)
Historical Stock Chart
From Jun 2024 to Jul 2024
Biogen (TG:IDP)
Historical Stock Chart
From Jul 2023 to Jul 2024