Press Release: Dupixent approved in China as the first-ever
biologic medicine for patients with COPD
Dupixent approved in China as the first-ever
biologic medicine for patients with COPD
- Approval follows EU approval of
Dupixent for adults with COPD with raised blood eosinophils, and is
based on two landmark phase 3 studies showing Dupixent
significantly reduced exacerbations, improved lung function, and
also improved health-related quality of life
- COPD is the most prevalent chronic
respiratory disease in China, and is a priority within the
government’s Healthy China 2030 public health plan
- Dupixent is now approved in four
indications across respiratory and dermatological diseases in
China
Paris and Tarrytown, New York, Sept. 27,
2024. The National Medical Products Administration (NMPA)
in China has approved Dupixent (dupilumab) as an add-on maintenance
treatment for adults with uncontrolled chronic obstructive
pulmonary disease (COPD) characterized by raised blood eosinophils.
Specifically, the approval covers patients already on a combination
of an inhaled corticosteroid (ICS), a long-acting beta2-agonist
(LABA) and a long-acting muscarinic antagonist (LAMA), or on a
combination of a LABA and a LAMA if ICS is not appropriate.
Dupixent for the treatment of COPD has been approved in more than
30 countries worldwide, including the 27 countries in the EU.
Professor Kang
Jian
Chair of COPD Branch, Chinese Association of Chest Physicians,
CMDA, Respiratory Department of First Hospital of China Medical
University
“The impact of COPD extends far beyond the patient.
Debilitating breathlessness and irreversible lung damage make it
difficult for patients to do simple daily tasks, placing a
significant burden on family members, the central caregivers in
Chinese families. The approval of Dupixent for COPD in China is
critical, as it fills a gap in targeted therapy for the disease and
provides clinicians with a new treatment approach. This offers new
hope for COPD patients who remain inadequately controlled even
after triple therapy, as well as those who care for them."
Houman Ashrafian, MD,
PhD
Executive Vice President, Head of Research and Development at
Sanofi
“China has the largest number of people living with COPD
worldwide, and a significant proportion of patients are
uncontrolled on current therapies and desperate for an effective
treatment option. The Dupixent COPD clinical program has furthered
our scientific understanding of COPD, and given us a new way to
think about which patients could benefit most from such a
treatment. With its well-established safety and efficacy profile,
Dupixent is a long-awaited advancement for patients, caregivers,
and physicians who are desperate for a new treatment
option.”
Despite the high prevalence and burden of COPD
in China, public awareness is limited. The Healthy China 2030
public health initiative includes a focus on addressing chronic
respiratory diseases like COPD and aims to improve the quality of
life for patients with COPD.
The approval is based on results from the
landmark BOREAS and NOTUS phase 3 studies, which evaluated the
efficacy and safety of Dupixent in adults with uncontrolled COPD
with raised blood eosinophils. All patients were on background
maximal standard-of-care inhaled therapy (nearly all on triple
therapy). Dupixent significantly reduced COPD exacerbations by 30%
and 34% compared to placebo in the BOREAS and NOTUS studies
respectively. Dupixent significantly and rapidly improved lung
function compared to placebo, with improvements sustained at 52
weeks. Improvements in health-related quality of life
(statistically significant in BOREAS and nominally significant in
NOTUS) compared to placebo were also observed, as assessed by the
St. George’s Respiratory Questionnaire (SGRQ). Data from both
studies were published in separate manuscripts in The New
England Journal of Medicine (BOREAS and NOTUS).
Safety results in both studies were generally
consistent with the known safety profile of Dupixent in its
approved indications. The most common side effects across
indications include injection site reactions, conjunctivitis,
conjunctivitis allergic, arthralgia, oral herpes, and eosinophilia.
Additional adverse reactions of injection site bruising, injection
site induration, injection site rash, and injection site dermatitis
were reported in the COPD studies. Adverse events more commonly
observed with Dupixent (≥5%) compared to placebo in either COPD
study were back pain, COVID-19, diarrhea, headache, and
nasopharyngitis.
George D. Yancopoulos, M.D.,
Ph.D.
Board co-Chair, President, and Chief Scientific Officer at
Regeneron
“One in four people with COPD live in China, and many patients
are unable to control their disease with standard of care
treatments and experience repeated hospitalizations from
exacerbations and debilitating limitations on their quality of
life. With millions of people in industrialized areas worldwide
facing increased risk for developing COPD, it is more important
than ever to deliver innovative new options for this complex and
notoriously difficult-to-treat disease. With this latest Dupixent
approval, patients in China have a novel treatment approach that
has shown groundbreaking results by reducing exacerbations while
also improving lung function and supporting a better quality of
life.”
Additional submissions for Dupixent in COPD are
under review with regulatory authorities around the world,
including in the US and Japan.
About COPD
COPD is a respiratory disease that damages the lungs and causes
progressive lung function decline. Symptoms include persistent
cough, excessive mucus production, and shortness of breath that may
impair the ability to perform routine daily activities, which may
lead to sleep disturbances, anxiety and depression. COPD is also
associated with a significant health and economic burden due to
recurrent acute exacerbations that require systemic corticosteroid
treatment and/or lead to hospitalization. Smoking and exposure to
noxious particles are key risk factors for COPD, but even
individuals who quit smoking can still have progressive lung
disease.
About half of COPD patients continue to
experience exacerbations despite being on triple inhaled therapy.
Patients with an eosinophilic phenotype contribute to a ~30%
increase in exacerbations and an increased risk of COPD-related
re-hospitalizations within a year.
About Sanofi and Regeneron’s COPD Clinical
Research Program
Sanofi and Regeneron are motivated to transform the treatment
paradigm of COPD by examining the role different types of
inflammation play in the disease progression through the
investigation of two potentially first-in-class biologics, Dupixent
and itepekimab.
Dupixent inhibits the signaling of the
interleukin-4 (IL4) and interleukin-13 (IL13) pathways and the
program focuses on a specific population of people with evidence of
type-2 inflammation. Itepekimab is a fully human monoclonal
antibody that binds to and inhibits interleukin-33 (IL33), an
initiator and amplifier of broad inflammation in COPD.
Itepekimab is currently under clinical
investigation for COPD in two phase 3 studies and its safety and
efficacy have not been evaluated by any regulatory authority.
About Dupixent
Dupixent is available in China in a 300 mg dose as a pre-filled
syringe or pre-filled pen and is now available for COPD. Dupixent
is intended for injection under the skin (subcutaneous injection)
and is given every other week. It can be given in a clinic or at
home by self-administration after training by a healthcare
professional.
Dupixent (dupilumab) is a fully human monoclonal
antibody that inhibits the signaling of the interleukin-4 (IL4) and
interleukin-13 (IL13) pathways and is not an immunosuppressant. The
Dupixent development program has shown significant clinical benefit
and a decrease in type-2 inflammation in phase 3 studies,
establishing that IL4 and IL13 are key and central drivers of the
type-2 inflammation that plays a major role in multiple related and
often co-morbid diseases.
Dupixent has received regulatory approvals in
more than 60 countries in one or more indications including certain
patients with atopic dermatitis, asthma, chronic rhinosinusitis
with nasal polyps, eosinophilic esophagitis, prurigo nodularis,
chronic spontaneous urticaria, and COPD in different age
populations. More than 1,000,000 patients are being treated with
Dupixent globally.
Dupilumab development program
Dupilumab is being jointly developed by Sanofi and Regeneron under
a global collaboration agreement. To date, dupilumab has been
studied across more than 60 clinical studies involving more than
10,000 patients with various chronic diseases driven in part by
type-2 inflammation.
In addition to the currently approved
indications, Sanofi and Regeneron are studying dupilumab in a broad
range of diseases driven by type-2 inflammation or other allergic
processes in phase 3 studies, including chronic pruritus of unknown
origin and bullous pemphigoid. These potential uses of dupilumab
are currently under clinical investigation, and the safety and
efficacy in these conditions have not been fully evaluated by any
regulatory authority.
About Regeneron
Regeneron (NASDAQ: REGN) is a leading biotechnology company that
invents, develops and commercializes life-transforming medicines
for people with serious diseases. Founded and led by
physician-scientists, our unique ability to repeatedly and
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and inflammatory diseases, cancer, cardiovascular and metabolic
diseases, neurological diseases, hematologic conditions, infectious
diseases, and rare diseases.
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discovery and accelerates drug development using our proprietary
technologies, such
as VelociSuite®, which
produces optimized fully human antibodies and new classes of
bispecific antibodies. We are shaping the next frontier of medicine
with data-powered insights from the Regeneron Genetics
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platforms, enabling us to identify innovative targets and
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For more information, please visit
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About Sanofi
We are an innovative global healthcare company, driven by one
purpose: we chase the miracles of science to improve people’s
lives. Our team, across the world, is dedicated to transforming the
practice of medicine by working to turn the impossible into the
possible. We provide potentially life-changing treatment options
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Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY
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