New Safety Data on treatment with COPAXONE® (glatiramer acetate) of Breastfeeding Mothers who Live with Relapsing Multiple S...
22 June 2021 - 4:30PM
Business Wire
- Non-interventional study analysis found no evidence of
safety concerns with infants of mothers with multiple sclerosis
(MS) who were breastfeeding and undergoing glatiramer acetate (GA)
treatment
- Maternal breastfeeding exposure to GA did not adversely
affect offspring with regard to hospitalisations and antibiotic
treatments, developmental delay, or growth in the first 18 months
of life
The COBRA study, a new real world evidence study undertaken by
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) and St.
Josef Hospital (Bochum, Germany), was presented today at EAN
congress and provided new insight on the use of COPAXONE®
(glatiramer acetate or GA) by mothers with multiple sclerosis (MS)
who are breastfeeding.
The study, which represents the largest analysis of child
outcomes breastfed by mothers under GA, assessed 120 mothers with
MS and their infants. It concluded that no evidence exists to
suggest that infants were adversely affected by maternal exposure
to glatiramer acetate while breastfeeding with regard to
hospitalisations and antibiotic treatments, developmental delay, or
growth in the first 18 months of life1.
“The benefits of breastfeeding for both mothers and their
offspring are clinically meaningful and well-documented, so it is
imperative to provide clinical evidence on safety of disease
modifying therapies (DMTs), so mothers with MS will no longer need
to give up breastfeeding while on treatment ” said Professor
Kerstin Hellwig, Principal Study Investigator, Department of
Neurology, St. Josef Hospital, Ruhr University Bochum, Germany
.
“Against the backdrop of the global COVID-19 pandemic, our
analysis, which included 60 offsprings in the glatiramer acetate
group and 60 in a control group (offspring of mothers with MS not
treated with any disease-modifying treatment during breastfeeding),
is an important contribution to this significant unmet medical
need. There is historically limited clinical safety data for
infants who are breastfed by mothers undergoing treatment for MS.
We found no evidence of developmental delay, body growth issues or
increased hospitalisation and antibiotic use in group of infants
from the glatiramer acetate cohort in comparison with controls.
The COBRA study used data from the National German Multiple
Sclerosis and Pregnancy Registry from 2011 to 2020. Patients were
eligible for the study if they were diagnosed with relapsing MS
(RMS), gave a live birth, were breastfeeding under GA treatment
(Copaxone® 20 or 40 mg/mL) or breastfeeding under no DMT
treatment.
Danilo Lembo M.D. VP Medical Europe, Teva Pharmaceuticals
comments: “We are hugely grateful to this study for its work.
According to data available, every third woman with MS may
experience disease reactivation after childbirth 2. Slowing disease
progression, control of relapses and breastfeeding are priorities
for many patients, especially in this particularly fragile period.
Our mission at Teva is to improve the lives of patients. That
includes helping to benefit from important medicines throughout
life’s stages, and during family planning in particular.”
The data presentation follows extensive ongoing study of
glatiramer acetate in a variety of real-world settings. For the
past years, studies and leading MS experts have generally advised
against the use of DMTs while breastfeeding infants and the
postponing of breastfeeding for three months following the last
dose of any disease-modifying drug3.
About the Study
“Real-world safety of Copaxone in Offspring of
Breastfeeding and Treated Relapsing Multiple
Sclerosis (RMS) pAtients” (COBRA study) was retrospective
data analysis using the national German Multiple Sclerosis and
Pregnancy Registry. 60 offspring from the glatiramer acetate (GA)
cohort (59 pregnancies; 58 women) and 60 from the control (60
pregnancies; 60 women) were included. Maternal demographics and RMS
prognostic factors were descriptively comparable between cohorts.
“Cumulative” maternal GA-exposure was higher in the GA cohort vs
control, because 86.7% of offspring’s mothers received GA also at
some point during pregnancy (vs 25%).
Safety outcomes in ≤18 months of postpartum follow up showed
similar between cohorts, offspring frequency and incidence of
hospitalisations. Annualized number of hospitalisations was 0.20
[95% confidence interval {CI}=0.09–0.31] in the GA cohort vs the
control (0.25 [95% CI=0.12–0.38]). Frequency and incidence of
antibiotic use were similar between cohorts. Growth parameters
(body weight, body length and head circumference) were also
comparable between cohorts at birth as well as at each time point
studied. Paediatrician check-ups at 12 months identified 3 (2.5%;
N=120 [95% CI=0.52–7.13]) offspring with developmental delays; all
in the control cohort (n=60; 5% [95% CI=1.04–13.92]).
About COPAXONE®
COPAXONE® (glatiramer acetate injection) is indicated for the
treatment of patients with relapsing forms of multiple sclerosis.
The most common side effects of COPAXONE® are redness, pain,
swelling, itching, or a lump at the site of injection, flushing,
rash, shortness of breath, and chest pain. The use of COPAXONE®
during breastfeeding should be decided by weighing the benefit of
breastfeeding for the child and the benefit of therapy for the
woman. See additional important information at:
www.CopaxonePrescribingInformation.com. For hardcopy releases,
please see enclosed full prescribing information. The COPAXONE®
brand is approved in more than 50 countries worldwide, including
the United States, Russia, Canada, Mexico, Australia, Israel, and
all European countries.
About Teva
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) has
been developing and producing medicines to improve people’s lives
for more than a century. We are a global leader in generic and
specialty medicines with a portfolio consisting of over 3,500
products in nearly every therapeutic area. Around 200 million
people around the world take a Teva medicine every day and are
served by one of the largest and most complex supply chains in the
pharmaceutical industry. Along with our established presence in
generics, we have significant innovative research and operations
supporting our growing portfolio of specialty and biopharmaceutical
products. Learn more at www.tevapharm.com.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of
1995, which are based on management’s current beliefs and
expectations and are subject to substantial risks and
uncertainties, both known and unknown, that could cause our future
results, performance or achievements to differ significantly from
that expressed or implied by such forward-looking statements.
Important factors that could cause or contribute to such
differences include risks relating to:
- our ability to successfully compete in the marketplace,
including: that we are substantially dependent on our generic
products; consolidation of our customer base and commercial
alliances among our customers; delays in launches of new generic
products; the increase in the number of competitors targeting
generic opportunities and seeking U.S. market exclusivity for
generic versions of significant products; our ability to develop
and commercialize biopharmaceutical products; competition for our
specialty products, including AUSTEDO®, AJOVY® and COPAXONE®; our
ability to achieve expected results from investments in our product
pipeline; our ability to develop and commercialize additional
pharmaceutical products; and the effectiveness of our patents and
other measures to protect our intellectual property rights;
- our substantial indebtedness, which may limit our ability to
incur additional indebtedness, engage in additional transactions or
make new investments, may result in a further downgrade of our
credit ratings; and our inability to raise debt or borrow funds in
amounts or on terms that are favorable to us;
- our business and operations in general, including: uncertainty
regarding the COVID-19 pandemic and its impact on our business,
financial condition, operations, cash flows, and liquidity and on
the economy in general; our ability to successfully execute and
maintain the activities and efforts related to the measures we have
taken or may take in response to the COVID-19 pandemic and
associated costs therewith; effectiveness of our optimization
efforts; our ability to attract, hire and retain highly skilled
personnel; manufacturing or quality control problems; interruptions
in our supply chain; disruptions of information technology systems;
breaches of our data security; variations in intellectual property
laws; challenges associated with conducting business globally,
including political or economic instability, major hostilities or
terrorism; costs and delays resulting from the extensive
pharmaceutical regulation to which we are subject or delays in
governmental processing time due to travel and work restrictions
caused by the COVID-19 pandemic;
- the effects of reforms in healthcare regulation and reductions
in pharmaceutical pricing, reimbursement and coverage; significant
sales to a limited number of customers; our ability to successfully
bid for suitable acquisition targets or licensing opportunities, or
to consummate and integrate acquisitions; and our prospects and
opportunities for growth if we sell assets;
- compliance, regulatory and litigation matters, including:
failure to comply with complex legal and regulatory environments;
increased legal and regulatory action in connection with public
concern over the abuse of opioid medications and our ability to
reach a final resolution of the remaining opioid-related
litigation; scrutiny from competition and pricing authorities
around the world, including our ability to successfully defend
against the U.S. Department of Justice criminal charges of Sherman
Act violations; potential liability for patent infringement;
product liability claims; failure to comply with complex Medicare
and Medicaid reporting and payment obligations; compliance with
anti-corruption sanctions and trade control laws; and environmental
risks;
- other financial and economic risks, including: our exposure to
currency fluctuations and restrictions as well as credit risks;
potential impairments of our intangible assets; potential
significant increases in tax liabilities (including as a result of
potential tax reform in the United States); and the effect on our
overall effective tax rate of the termination or expiration of
governmental programs or tax benefits, or of a change in our
business; and other factors discussed in this press release, in our
Quarterly Report on Form 10-Q for the first quarter of 2021 and in
our Annual Report on Form 10-K for the year ended December 31,
2020, including in the sections captioned "Risk Factors” and
“Forward Looking Statements.” Forward-looking statements speak only
as of the date on which they are made, and we assume no obligation
to update or revise any forward-looking statements or other
information contained herein, whether as a result of new
information, future events or otherwise. You are cautioned not to
put undue reliance on these forward-looking statements.
References
- A. Ciplea et. Al, Safety analysis of offspring breastfed by
mothers on glatiramer acetate therapy for relapsing multiple
sclerosis; presented at EAN 2021.
- Saneea Almas, Jesse Vance, Teresa Baker, and Thomas Hale,
Management of Multiple Sclerosis in the Breastfeeding Mother,
Multiple Sclerosis International Volume 2016, Article ID 6527458,
http://dx.doi.org/10.1155/2016/6527458
- Pakpoor J, Disanto G, Lacey MV, Hellwig K, Giovannoni G,
Ramagopalan, Breastfeeding and multiple sclerosis relapses: a
meta-analysis. SVJ Neurol. 2012 Oct; 259(10):2246-8.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20210621005185/en/
Media Enquiries Fiona Cohen, Teva Europe + 31 6 2008 2545
Fiona.cohen@tevaeu.com
PR contact Con Franklin, Ketchum UK +44 (0) 7974 434 151
con.franklin@ketchum.com
Teva Pharmaceutical Indu... (NYSE:TEVA)
Historical Stock Chart
From Mar 2024 to Apr 2024
Teva Pharmaceutical Indu... (NYSE:TEVA)
Historical Stock Chart
From Apr 2023 to Apr 2024