Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today
announced that 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 European Union (EU).
“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,” said
Professor Kang Jian, Chair of COPD Branch, Chinese Association of
Chest Physicians, CMDA, Respiratory Department of First Hospital of
China Medical University. “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.”
“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,” said George D. Yancopoulos, M.D., Ph.D., Board co-Chair,
President and Chief Scientific Officer at Regeneron, and a
principal inventor of Dupixent. “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.”
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 trials, 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 trials 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 trials were published in
separate manuscripts in The New England Journal of Medicine (BOREAS
and NOTUS).
Safety results in both trials 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
trials. Adverse events more commonly observed with Dupixent (≥5%)
compared to placebo in either COPD trial were back pain, COVID-19,
diarrhea, headache and nasopharyngitis.
“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,” said Houman Ashrafian, M.D., Ph.D., Executive
Vice President, Head of Research and Development at Sanofi. “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.”
Additional submissions for Dupixent in COPD are under review
with regulatory authorities around the world, including in the U.S.
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 Regeneron and Sanofi’s COPD Clinical Research
ProgramRegeneron and Sanofi 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 (IL-4) and
interleukin-13 (IL-13) 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 (IL-33), an initiator and amplifier of
broad inflammation in COPD.
Itepekimab is currently under clinical investigation for COPD in
two Phase 3 trials 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, which was invented using Regeneron’s
proprietary VelocImmune® technology, is a fully human
monoclonal antibody that inhibits the signaling of the IL-4 and
IL-13 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 trials, establishing
that IL-4 and IL-13 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.
About Regeneron's
VelocImmune®
TechnologyRegeneron's VelocImmune technology
utilizes a proprietary genetically engineered mouse platform
endowed with a genetically humanized immune system to produce
optimized fully human antibodies. When Regeneron's co-Founder,
President and Chief Scientific Officer George D. Yancopoulos was a
graduate student with his mentor Frederick W. Alt in 1985, they
were the first to envision making such a genetically humanized
mouse, and Regeneron has spent decades inventing and developing
VelocImmune and related VelociSuite® technologies. Dr. Yancopoulos
and his team have used VelocImmune technology to create a
substantial portion of all original, FDA-approved or authorized
fully human monoclonal antibodies. This includes REGEN-COV®
(casirivimab and imdevimab), Dupixent, Libtayo® (cemiplimab-rwlc),
Praluent® (alirocumab), Kevzara® (sarilumab), Evkeeza®
(evinacumab-dgnb), Inmazeb® (atoltivimab, maftivimab and
odesivimab-ebgn), and Veopoz® (pozelimab-bbf).
Dupilumab Development ProgramDupilumab is being
jointly developed by Regeneron and Sanofi under a global
collaboration agreement. To date, dupilumab has been studied across
more than 60 clinical trials involving more than 10,000 patients
with various chronic diseases driven in part by type 2
inflammation.
In addition to the currently approved indications, Regeneron and
Sanofi are studying dupilumab in a broad range of diseases driven
by type 2 inflammation or other allergic processes in Phase 3
trials, 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.
U.S. INDICATIONS DUPIXENT is a prescription
medicine used:
- to treat adults and children 6 months of age and older with
moderate-to-severe eczema (atopic dermatitis or AD) that is not
well controlled with prescription therapies used on the skin
(topical), or who cannot use topical therapies. DUPIXENT can be
used with or without topical corticosteroids. It is not known if
DUPIXENT is safe and effective in children with atopic dermatitis
under 6 months of age.
- with other asthma medicines for the maintenance treatment of
moderate-to-severe eosinophilic or oral steroid dependent asthma in
adults and children 6 years of age and older whose asthma is not
controlled with their current asthma medicines. DUPIXENT helps
prevent severe asthma attacks (exacerbations) and can improve your
breathing. DUPIXENT may also help reduce the amount of oral
corticosteroids you need while preventing severe asthma attacks and
improving your breathing. DUPIXENT is not used to treat sudden
breathing problems. It is not known if DUPIXENT is safe and
effective in children with asthma under 6 years of age.
- with other medicines for the maintenance treatment of chronic
rhinosinusitis with nasal polyps (CRSwNP) in adults and children 12
years of age and older whose disease is not controlled. It is not
known if DUPIXENT is safe and effective in children with chronic
rhinosinusitis with nasal polyps under 12 years of age.
- to treat adults and children 1 year of age and older with
eosinophilic esophagitis (EoE), who weigh at least 33 pounds (15
kg). It is not known if DUPIXENT is safe and effective in children
with eosinophilic esophagitis under 1 year of age, or who weigh
less than 33 pounds (15 kg).
- to treat adults with prurigo nodularis (PN). It is not known if
DUPIXENT is safe and effective in children with prurigo nodularis
under 18 years of age.
IMPORTANT SAFETY INFORMATIONDo not
use if you are allergic to dupilumab or to any of the
ingredients in DUPIXENT®.Before using DUPIXENT, tell your
healthcare provider about all your medical conditions, including if
you:
- have eye problems.
- have a parasitic (helminth) infection.
- are scheduled to receive any vaccinations. You should not
receive a “live vaccine” right before and during treatment with
DUPIXENT.
- are pregnant or plan to become pregnant. It is not known
whether DUPIXENT will harm your unborn baby.
- A pregnancy registry for women who take DUPIXENT during
pregnancy collects information about the health of you and your
baby. To enroll or get more information call 1-877-311-8972 or go
to https://mothertobaby.org/ongoing-study/dupixent/
- are breastfeeding or plan to breastfeed. It is not known
whether DUPIXENT passes into your breast milk.
Tell your healthcare provider about all the medicines you take,
including prescription and over-the-counter medicines, vitamins,
and herbal supplements.Especially tell your healthcare
provider if you are taking oral, topical, or inhaled
corticosteroid medicines; have asthma and use an asthma medicine;
or have atopic dermatitis, chronic rhinosinusitis with nasal
polyps, eosinophilic esophagitis, or prurigo nodularis and also
have asthma. Do not change or stop your
corticosteroid medicine or other asthma medicine without talking to
your healthcare provider. This may cause other symptoms that were
controlled by the corticosteroid medicine or other asthma medicine
to come back.DUPIXENT can cause serious side effects,
including:
- Allergic reactions. DUPIXENT can cause allergic
reactions that can sometimes be severe. Stop using
DUPIXENT and tell your healthcare provider or get emergency help
right away if you get any of the following signs or symptoms:
breathing problems or wheezing, swelling of the face, lips, mouth,
tongue or throat, fainting, dizziness, feeling lightheaded, fast
pulse, fever, hives, joint pain, general ill feeling, itching, skin
rash, swollen lymph nodes, nausea or vomiting, or cramps in your
stomach-area.
- Eye problems. Tell your healthcare provider if
you have any new or worsening eye problems, including eye pain or
changes in vision, such as blurred vision. Your healthcare provider
may send you to an ophthalmologist for an exam if needed.
- Inflammation of your blood vessels. Rarely,
this can happen in people with asthma who receive DUPIXENT. This
may happen in people who also take a steroid medicine by mouth that
is being stopped or the dose is being lowered. It is not known
whether this is caused by DUPIXENT. Tell your healthcare provider
right away if you have: rash, chest pain, worsening shortness of
breath, a feeling of pins and needles or numbness of your arms or
legs, or persistent fever.
- Joint aches and pain. Some people who use
DUPIXENT have had trouble walking or moving due to their joint
symptoms, and in some cases needed to be hospitalized. Tell your
healthcare provider about any new or worsening joint symptoms. Your
healthcare provider may stop DUPIXENT if you develop joint
symptoms.
The most common side effects include:
- Eczema: injection site reactions, eye and
eyelid inflammation, including redness, swelling, and itching,
sometimes with blurred vision, dry eye, cold sores in your mouth or
on your lips, and high count of a certain white blood cell
(eosinophilia).
- Asthma: injection site reactions, high count
of a certain white blood cell (eosinophilia), pain in the throat
(oropharyngeal pain), and parasitic (helminth) infections.
- Chronic Rhinosinusitis with Nasal Polyps:
injection site reactions, eye and eyelid inflammation, including
redness, swelling, and itching, sometimes with blurred vision, high
count of a certain white blood cell (eosinophilia), gastritis,
joint pain (arthralgia), trouble sleeping (insomnia), and
toothache.
- Eosinophilic Esophagitis: injection site
reactions, upper respiratory tract infections, cold sores in your
mouth or on your lips, and joint pain (arthralgia).
- Prurigo Nodularis: eye and eyelid
inflammation, including redness, swelling, and itching, sometimes
with blurred vision, herpes virus infections, common cold symptoms
(nasopharyngitis), dizziness, muscle pain, and diarrhea.
Tell your healthcare provider if you have any side effect that
bothers you or that does not go away. These are not all the
possible side effects of DUPIXENT. Call your doctor for medical
advice about side effects. You are encouraged to report negative
side effects of prescription drugs to the FDA. Visit
http://www.fda.gov/medwatch, or call 1-800-FDA-1088.Use DUPIXENT
exactly as prescribed by your healthcare provider. It’s an
injection given under the skin (subcutaneous injection). Your
healthcare provider will decide if you or your caregiver can inject
DUPIXENT. Do not try to prepare and inject
DUPIXENT until you or your caregiver have been trained by your
healthcare provider. In children 12 years of age and older, it’s
recommended DUPIXENT be administered by or under supervision of an
adult. In children 6 months to less than 12 years of age, DUPIXENT
should be given by a caregiver.
Please see accompanying full
Prescribing Information including Patient
Information.
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
medicine has led to numerous approved treatments and product
candidates in development, most of which were homegrown in our
laboratories. Our medicines and pipeline are designed to help
patients with eye diseases, allergic and inflammatory diseases,
cancer, cardiovascular and metabolic diseases, neurological
diseases hematologic conditions, infectious diseases, and rare
diseases.
Regeneron pushes the boundaries of scientific 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 Center® and pioneering genetic medicine
platforms, enabling us to identify innovative targets and
complementary approaches to potentially treat or cure diseases.
For more information , please visit www.Regeneron.com or follow
Regeneron on LinkedIn, Instagram, Facebook or X.
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
dedicated to transforming the practice of medicine by working to
turn the impossible into the possible. We provide potentially
life-changing treatment options and life-saving vaccine protection
to millions of people globally, while putting sustainability and
social responsibility at the center of our ambitions.
Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY
Regeneron Forward-Looking Statements and Use of Digital
MediaThis press release includes forward-looking
statements that involve risks and uncertainties relating to future
events and the future performance of Regeneron Pharmaceuticals,
Inc. (“Regeneron” or the “Company”), and actual events or results
may differ materially from these forward-looking statements. Words
such as “anticipate,” “expect,” “intend,” “plan,” “believe,”
“seek,” “estimate,” variations of such words, and similar
expressions are intended to identify such forward-looking
statements, although not all forward-looking statements contain
these identifying words. These statements concern, and these risks
and uncertainties include, among others, the nature, timing, and
possible success and therapeutic applications of products marketed
or otherwise commercialized by Regeneron and/or its collaborators
or licensees (collectively, “Regeneron’s Products”) and product
candidates being developed by Regeneron and/or its collaborators or
licensees (collectively, “Regeneron’s Product Candidates”) and
research and clinical programs now underway or planned, including
without limitation Dupixent® (dupilumab) as an add-on maintenance
treatment for adults with uncontrolled chronic obstructive
pulmonary disease characterized by raised blood
eosinophils (“COPD”); uncertainty of the utilization, market
acceptance, and commercial success of Regeneron’s Products and
Regeneron’s Product Candidates and the impact of studies (whether
conducted by Regeneron or others and whether mandated or
voluntary), including the studies discussed or referenced in this
press release, on any of the foregoing or any potential regulatory
approval of Regeneron’s Products (such as Dupixent) and Regeneron’s
Product Candidates (such as itepekimab); the likelihood, timing,
and scope of possible regulatory approval and commercial launch of
Regeneron’s Product Candidates and new indications for Regeneron’s
Products, such as Dupixent for the treatment of COPD in the United
States, Japan, and other jurisdictions as well as Dupixent for the
treatment of chronic pruritus of unknown origin, bullous
pemphigoid, and other potential indications; the ability of
Regeneron’s collaborators, licensees, suppliers, or other third
parties (as applicable) to perform manufacturing, filling,
finishing, packaging, labeling, distribution, and other steps
related to Regeneron’s Products and Regeneron’s Product Candidates;
the ability of Regeneron to manage supply chains for multiple
products and product candidates; safety issues resulting from the
administration of Regeneron’s Products (such as Dupixent) and
Regeneron’s Product Candidates (such as itepekimab) in patients,
including serious complications or side effects in connection with
the use of Regeneron’s Products and Regeneron’s Product Candidates
in clinical trials; determinations by regulatory and administrative
governmental authorities which may delay or restrict Regeneron’s
ability to continue to develop or commercialize Regeneron’s
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and clinical programs, and business, including those relating to
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payer healthcare and insurance programs, health maintenance
organizations, pharmacy benefit management companies, and
government programs such as Medicare and Medicaid; coverage and
reimbursement determinations by such payers and new policies and
procedures adopted by such payers; competing drugs and product
candidates that may be superior to, or more cost effective than,
Regeneron’s Products and Regeneron’s Product Candidates; the extent
to which the results from the research and development programs
conducted by Regeneron and/or its collaborators or licensees may be
replicated in other studies and/or lead to advancement of product
candidates to clinical trials, therapeutic applications, or
regulatory approval; unanticipated expenses; the costs of
developing, producing, and selling products; the ability of
Regeneron to meet any of its financial projections or guidance and
changes to the assumptions underlying those projections or
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agreement, including Regeneron’s agreements with Sanofi and Bayer
(or their respective affiliated companies, as applicable) to be
cancelled or terminated; the impact of public health outbreaks,
epidemics, or pandemics (such as the COVID-19 pandemic) on
Regeneron's business; and risks associated with intellectual
property of other parties and pending or future litigation relating
thereto (including without limitation the patent litigation and
other related proceedings relating to EYLEA® (aflibercept)
Injection), other litigation and other proceedings and government
investigations relating to the Company and/or its operations
(including the pending civil proceedings initiated or joined by the
U.S. Department of Justice and the U.S. Attorney's Office for the
District of Massachusetts), the ultimate outcome of any such
proceedings and investigations, and the impact any of the foregoing
may have on Regeneron’s business, prospects, operating results, and
financial condition. A more complete description of these and other
material risks can be found in Regeneron’s filings with the U.S.
Securities and Exchange Commission, including its Form 10-K for the
year ended December 31, 2023 and its Form 10-Q for the quarterly
period ended June 30, 2024. Any forward-looking statements are made
based on management’s current beliefs and judgment, and the reader
is cautioned not to rely on any forward-looking statements made by
Regeneron. Regeneron does not undertake any obligation to update
(publicly or otherwise) any forward-looking statement, including
without limitation any financial projection or guidance, whether as
a result of new information, future events, or otherwise.Regeneron
uses its media and investor relations website and social media
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including information that may be deemed material to investors.
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Sanofi Disclaimers or Forward-Looking
StatementsThis press release contains forward-looking
statements as defined in the Private Securities Litigation Reform
Act of 1995, as amended. Forward-looking statements are statements
that are not historical facts. These statements include projections
and estimates regarding the marketing and other potential of the
product, or regarding potential future revenues from the product.
Forward-looking statements are generally identified by the words
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“plans” and similar expressions. Although Sanofi’s management
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All trademarks mentioned in this press release are the property
of the Sanofi group apart from VelociSuite and Regeneron Genetics
Center.
Regeneron
Contacts:Media RelationsHannah
KwaghTel: +1 914-847-6314Hannah.kwagh@regeneron.com |
Investor
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Sanofi
Contacts:Media RelationsSandrine
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40Victor.Rouault@sanofi.comTimothy GilbertTel: +1
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Investor
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513 693Thomas.Larsen@sanofi.comAlizé
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