Interferon Beta Treatments, Including PLEGRIDY® (peginterferon
beta-1a) and AVONEX® (interferon beta-1a), Receive Positive CHMP
Opinion for Use During Pregnancy and Breastfeeding
Biogen Inc. (Nasdaq: BIIB) today announced that
the Committee for Medicinal Products for Human Use (CHMP),
part of the of the European Medicines Agency (EMA), recommended an
update to marketing authorizations of approved interferon beta
treatments, including PLEGRIDY® (peginterferon beta-1a) and AVONEX®
(interferon beta-1a), to remove pregnancy contraindications and,
where clinically needed, to allow use during pregnancy and
breastfeeding in women with relapsing multiple sclerosis (MS).
“Women are diagnosed with MS at least two to three times more
frequently than men,1 and the disease may strike during their
child-bearing years.2 Choosing a treatment plan that allows women
to continue or start their MS therapy while pregnant or
breastfeeding is a step forward for those living with this chronic,
debilitating disease and their partners,” said Alfred Sandrock,
Jr., M.D., Ph.D., executive vice president and chief medical
officer at Biogen. “This CHMP opinion gives physicians and their
patients added confidence when considering treatment with PLEGRIDY
or AVONEX, two important therapies for relapsing MS that have been
prescribed to more than half a million people living with the
disease.”
The CHMP opinion is based on data from the European Interferon
Beta Pregnancy Registry, as well as the national health registers
in Finland and Sweden, which together created the largest cohort
studies providing safety data related to interferon beta exposure
in women of child-bearing age with MS.
Data collected from more than 1,000 pregnancy outcomes from
registries and post-marketing experience indicate no increased risk
of major congenital anomalies following exposure to interferon beta
before conception or during the first trimester of pregnancy.
However, the duration of exposure during the first trimester is
uncertain, because data were collected when interferon beta use was
contraindicated during pregnancy, and treatment was likely
interrupted when the pregnancy was detected and/or confirmed.
Additionally, experience with exposure in the second and third
trimesters is very limited. The risk of spontaneous abortions in
pregnant women exposed to interferon beta cannot adequately be
evaluated based on the currently available data, but the data do
not suggest an increased risk so far. Limited data suggest the
levels of interferon beta-1a excreted in human milk are negligible,
and no harmful effects on the breastfed newborn/infant are
anticipated.
About PLEGRIDY® PLEGRIDY is a
subcutaneous pegylated interferon dosed once every two weeks for
relapsing forms of MS, including relapsing-remitting MS
(RRMS), 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. Nearly 50,000 people
worldwide have been treated with PLEGRIDY, with
over 88,000 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 is supported by one of the
largest pivotal studies with interferons conducted in people living
with RRMS. 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 favorable 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.
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 AVONEX® AVONEX is one of the most
prescribed treatments for relapsing forms of MS worldwide and is
currently approved in over 90 countries. Over 550,000 people
worldwide have been treated with AVONEX, with over 2.6
million patient-years of experience, based on prescription data.4
AVONEX is indicated for the treatment of patients with
relapsing forms of MS to slow the accumulation of physical
disability and decrease the frequency of clinical exacerbations.
Patients with MS in whom efficacy has been demonstrated include
patients who have experienced a first clinical episode and have MRI
features consistent with MS.
Symptoms of depression, suicidal ideation or psychosis, and
cases of suicide, have been reported with increased frequency with
patients receiving AVONEX. Severe hepatic injury, including cases
of hepatic failure has been reported rarely in patients. Rare cases
of anaphylaxis have been reported. While beta interferons do not
have any known direct cardiac toxicity, cases of congestive heart
failure, cardiomyopathy and cardiomyopathy with congestive heart
failure have been reported in patients without known
predisposition. Decreased peripheral blood counts have been
reported from postmarketing experience. Seizures have been reported
in patients using AVONEX, including patients with no prior history
of seizure. Autoimmune disorders of multiple target organs have
been reported. Routine periodic blood chemistry, hematology, liver
function and thyroid function tests are recommended.
Please click here for Important Safety
Information and full Prescribing Information,
including Medication Guide for AVONEX in the U.S., or visit
your respective country’s product website.
About Biogen At 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, and today 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, neuromuscular disorders, movement disorders,
Alzheimer’s disease and dementia, 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
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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 the potential benefits, safety and
efficacy of PLEGRIDY and AVONEX; the results of certain real-world
data; our research and development program for the treatment of MS;
plans for additional regulatory filings in other jurisdictions; and
risks and uncertainties associated with drug development and
commercialization. These statements may be identified by words such
as “aim,” “anticipate,” “believe,” “could,” “estimate,” “except,”
“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 the occurrence of
adverse safety events and/or unexpected concerns that may arise
from additional data or analysis; failure to obtain regulatory
approvals in other jurisdictions; regulatory authorities may
require additional information or further studies, or may fail to
approve or may delay approval of expansion of product labeling;
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; and product liability claims. 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.
_______________1 Multiple Sclerosis Coalition. The Use of
Disease-modifying Therapies in Multiple Sclerosis Principles and
Current Evidence. Updated March 2017.
http://www.nationalmssociety.org/getmedia/1e64b96c-9e55-400e-9a64-0cdf5e2d60fe/summaryDMTpaper_-final2
Coyle PK. Pregnancy and multiple sclerosis. Neurol Clin. 2012
Aug;30(3):877-88. doi: 10.1016/j.ncl.2012.05.002. Epub 2012 Jun
22.3 Salvetti M et al. Safety, Pregnancy Outcomes, and Clinical
Effectiveness of Peginterferon Beta-1a for Patients with Newly
Diagnosed and Non-Newly Diagnosed Relapsing Multiple Sclerosis:
Third Interim Analysis of the Plegridy Observational Program.
Poster presented at: 35th Annual ECTRIMS Congress; 2019 Sept 11-13;
Stockholm, Sweden.4 Benedict R et al. Change in Cognitive
Processing Speed is Associated with Cortical Grey Matter and
Thalamic Volume Loss in Patients with Relapsing-remitting Multiple
Sclerosis. Poster presented at: 35th Annual ECTRIMS Congress; 2019
Sept 11-13; Stockholm, Sweden.
MEDIA CONTACT: David Caouette+1 617 679
4945public.affairs@biogen.com |
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