Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today
announced that the U.S. Food and Drug Administration (FDA) has
accepted for Priority Review the supplemental Biologics License
Application (sBLA) for Dupixent® (dupilumab) as an add-on
maintenance treatment for adolescents aged 12 to 17 years with
inadequately controlled chronic rhinosinusitis with nasal polyposis
(CRSwNP). The target action date for the FDA decision is September
15, 2024. Dupixent is currently approved as an add-on maintenance
treatment for adults with CRSwNP whose disease is not adequately
controlled.
The sBLA in adolescents is supported by an extrapolation of
efficacy data from two positive pivotal trials (SINUS-24 and
SINUS-52) in adults with CRSwNP. These trials demonstrated that
Dupixent significantly improved nasal congestion/obstruction
severity, nasal polyp size and sense of smell, while also reducing
the need for systemic corticosteroids or surgery, at 24 weeks
compared to placebo. The sBLA was also supported by the safety data
of Dupixent in its currently approved indications for
adolescents.
Safety results in both SINUS-24 and SINUS-52 were generally
consistent with the known safety profile of Dupixent in its
approved indications. Adverse events more commonly observed with
Dupixent (≥3%) compared to placebo in SINUS-24 and SINUS-52
(24-week safety pool) were injection site reactions and
arthralgia.
Priority Review is granted to regulatory applications seeking
approval for therapies that have the potential to provide
significant improvements in the treatment, diagnosis or prevention
of serious conditions. The potential use of Dupixent in adolescents
with CRSwNP has not been fully evaluated by any regulatory
authority.
About CRSwNPCRSwNP is a chronic, recurring
disease of the upper airway driven in part by type 2 inflammation
that obstructs the sinuses and nasal passages. It can lead to
breathing difficulties, nasal congestion and discharge, reduced or
loss of sense of smell and taste, facial pressure, sleep
disturbance, and overall reduction in quality of life. Many
patients with CRSwNP have other type 2 inflammatory diseases, such
as asthma that is often more severe and difficult to treat. These
co-morbid diseases can lead to an increased risk of asthma attacks,
high symptom burden and a substantial adverse impact on
health-related quality of life. In the pivotal adult Dupixent
CRSwNP trials, 59% of patients also had asthma.
About DupixentDupixent, which was invented
using Regeneron’s proprietary VelocImmune® technology, is
a fully human monoclonal antibody that inhibits the signaling of
the interleukin-4 (IL-4) and interleukin-13 (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, CRSwNP, eosinophilic esophagitis
(EoE), prurigo nodularis and chronic spontaneous urticaria (CSU) in
different age populations. More than 850,000 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) and Inmazeb® (atoltivimab,
maftivimab and odesivimab-ebgn).
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 spontaneous urticaria, chronic
pruritus of unknown origin, chronic obstructive pulmonary disease
with evidence of type 2 inflammation 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
polyposis (CRSwNP) in adults whose disease is not controlled. It is
not known if DUPIXENT is safe and effective in children with
chronic rhinosinusitis with nasal polyposis under 18 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 INFORMATION
Do 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 polyposis, 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 Polyposis:
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 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 some 100
countries, 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); 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 adolescents aged 12
to 17 with inadequately controlled chronic rhinosinusitis with
nasal polyposis (including based on the supplemental Biologics
License Application discussed in this press release) as well as
Dupixent for the treatment of chronic spontaneous urticaria,
chronic pruritus of unknown origin, chronic obstructive pulmonary
disease with evidence of type 2 inflammation, bullous pemphigoid,
and other potential indications; 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; 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 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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obligations and oversight impacting Regeneron’s Products, research
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, 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. 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 outlets to publish
important information about the Company, including information that
may be deemed material to investors. Financial and other
information about Regeneron is routinely posted and is accessible
on Regeneron's media and investor relations website
(https://investor.regeneron.com) and its LinkedIn page
(https://www.linkedin.com/company/regeneron-pharmaceuticals).
Sanofi Disclaimers or Forward-Looking
StatementsThis press release contains forward-looking
statements as defined in the Private Securities Litigation Reform
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that are not historical facts. These statements include projections
and estimates regarding the marketing and other potential of the
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Forward-looking statements are generally identified by the words
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generally beyond the control of Sanofi, that could cause actual
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things, unexpected regulatory actions or delays, or government
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Regeneron Contacts:Media
RelationsAnna HodgeTel: +1
914-255-6475Anna.Hodge@regeneron.com |
Investor RelationsVesna TosicTel:
+1 914-847-5443Vesna.Tosic@regeneron.com |
Sanofi
Contacts:Media RelationsSally
BainTel: +1
617-834-6026Sally.Bain@sanofi.comVictor
RouaultTel: + 33 6 70 93 71
40Victor.Rouault@sanofi.comTimothy Gilbert Tel: +1
516 521 2929Timothy.Gilbert@sanofi.com Evan
Berland Tel: +1 215 432 0234Evan.Berland@sanofi.com |
Investor
RelationsThomas Kudsk Larsen Tel: +44
7545 513 693Thomas.Larsen@sanofi.comAlizé
Kaisserian Tel: + 33 (0)6 47 04 12
11Alize.Kaisserian@sanofi.comArnaud DelepineTel:
+33 (0)6 73 69 36 93Arnaud.Delepine@sanofi.comCorentine
DriancourtTel: +33 (0)6 40 56 92
21Corentine.Driancourt@sanofi.comFelix
LauscherTel: +1
908-612-7239Felix.Lauscher@sanofi.comNathalie
PhamTel: +33 (0)7 85 93 30
17Nathalie.Pham@sanofi.comTarik ElgoutniTel: +1
617-710-3587Tarik.Elgoutni@sanofi.com |
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