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 COPDCOPD 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 ProgramSanofi 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 DupixentDupixent 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
programDupilumab 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 RegeneronRegeneron (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 consistently translate science into
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About SanofiWe 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
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listed on EURONEXT: SAN and NASDAQ: SNY
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