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) in a sixth potential
indication as an add-on maintenance treatment in certain adult
patients with uncontrolled chronic obstructive pulmonary disease
(COPD). The target action date for the FDA decision is June 27,
2024. Regulatory submissions are under review in China and Europe.
The sBLA, as well as other submissions around the world, is
supported by data from the Phase 3 COPD clinical research program
evaluating the efficacy and safety of Dupixent in adults who were
current or former smokers with uncontrolled COPD with evidence of
type 2 inflammation (i.e., blood eosinophils ≥300 cells per μL).
All patients were on background maximal standard-of-care inhaled
therapy (nearly all on triple therapy). The primary endpoint was
met in both trials (BOREAS, NOTUS), showing Dupixent significantly
reduced annualized moderate or severe acute COPD exacerbations by
30% and 34%, respectively, compared to placebo. In both trials,
Dupixent rapidly and significantly improved lung function compared
to placebo, with improvements sustained at 52 weeks.
Safety results in both trials were generally consistent with the
known safety profile of Dupixent in its approved indications.
Adverse events more commonly observed with Dupixent (≥5%) compared
to placebo in either trial were back pain, COVID-19, diarrhea,
headache and nasopharyngitis.
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 COPD is
currently under clinical development, and its safety and efficacy
for this indication have not been fully evaluated by any regulatory
authority.
About COPDCOPD is a respiratory disease that
damages the lungs and causes progressive lung function decline.
Symptoms include persistent cough, breathlessness and excessive
mucus production that may not only impair the ability to perform
routine daily activities, but can also lead to anxiety, depression
and sleep disturbances. 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 develop or continue having the disease. There have been no
new treatment approaches approved for more than a decade.
In the U.S., approximately 300,000 people live with
uncontrolled COPD with evidence of type 2
inflammation.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, with two
Phase 3 trials currently enrolling, and its safety and efficacy
have not been evaluated by any regulatory authority.
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. These
diseases include approved indications for Dupixent, such as atopic
dermatitis, asthma, chronic rhinosinusitis with nasal polyposis
(CRSwNP), eosinophilic esophagitis (EoE), prurigo nodularis and
chronic spontaneous urticaria (CSU).
Dupixent has received regulatory approvals in one or more
countries around the world for use in certain patients with atopic
dermatitis, asthma, CRSwNP, EoE, prurigo nodularis or CSU in
different age populations. Dupixent is currently approved for one
or more of these indications in more than 60 countries, including
in Europe, the U.S. and Japan. Approximately
800,000 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 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 for over 35 years by
physician-scientists, our unique ability to repeatedly and
consistently translate science into medicine has led to numerous
FDA-approved treatments and product candidates in development,
almost all 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, hematologic conditions,
infectious diseases and rare diseases.
Regeneron is accelerating and improving the traditional drug
development process through our
proprietary VelociSuite® technologies, such
as VelocImmune®, which uses unique genetically humanized
mice to produce optimized fully human antibodies and bispecific
antibodies, and through ambitious research initiatives such as the
Regeneron Genetics Center, which is conducting one of the largest
genetics sequencing efforts in the world.
For more information about Regeneron, please
visit www.Regeneron.com or follow Regeneron
on LinkedIn.
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) and itepekimab for the
treatment of chronic obstructive pulmonary disease (“COPD”); 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 and
itepekimab for the treatment of COPD (including, in the case of
Dupixent, 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 (such as itepekimab); 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
Products and Regeneron’s Product Candidates; ongoing regulatory
obligations and oversight impacting Regeneron’s Products, research
and clinical programs, and business, including those relating to
patient privacy; the availability and extent of reimbursement of
Regeneron’s Products from third-party payers, including private
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
guidance; the potential for any license, collaboration, or supply
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
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
“expects”, “anticipates”, “believes”, “intends”, “estimates”,
“plans” and similar expressions. Although Sanofi’s management
believes that the expectations reflected in such forward-looking
statements are reasonable, investors are cautioned that
forward-looking information and statements are subject to various
risks and uncertainties, many of which are difficult to predict and
generally beyond the control of Sanofi, that could cause actual
results and developments to differ materially from those expressed
in, or implied or projected by, the forward-looking information and
statements. These risks and uncertainties include among other
things, unexpected regulatory actions or delays, or government
regulation generally, that could affect the availability or
commercial potential of the product, the fact that product may not
be commercially successful, the uncertainties inherent in research
and development, including future clinical data and analysis of
existing clinical data relating to the product, including post
marketing, unexpected safety, quality or manufacturing issues,
competition in general, risks associated with intellectual property
and any related future litigation and the ultimate outcome of such
litigation, and volatile economic and market conditions, and the
impact that pandemics or other global crises may have on us, our
customers, suppliers, vendors, and other business partners, and the
financial condition of any one of them, as well as on our employees
and on the global economy as a whole. The risks and uncertainties
also include the uncertainties discussed or identified in the
public filings with the SEC and the AMF made by Sanofi, including
those listed under “Risk Factors” and “Cautionary Statement
Regarding Forward-Looking Statements” in Sanofi’s annual report on
Form 20-F for the year ended December 31, 2022. Other than as
required by applicable law, Sanofi does not undertake any
obligation to update or revise any forward-looking information or
statements.
Regeneron Contacts:Media
RelationsHannah KwaghTel: +1
914-847-6314Hannah.Kwagh@regeneron.com |
Investor RelationsVesna TosicTel:
+1 914-847-5443Vesna.Tosic@regeneron.com |
Sanofi Contacts:Media
RelationsTimothy Gilbert Tel: +1 516 521
2929Timothy.Gilbert@sanofi.com |
Investor RelationsEva
Schaefer-JansenTel: +33 7 86 80 56
39Eva.Schaefer-Jansen@sanofi.com |
Victor Rouault Tel: +33 6 70 93 71
40Victor.Rouault@sanofi.com |
Arnaud DelepineTel: +33 (0)6 73 69 36
93Arnaud.Delepine@sanofi.com |
Evan
BerlandTel: +1 215 432 0234evan.berland@sanofi.com |
Corentine DriancourtTel: +33 (0)6 40 56 92
21Corentine.Driancourt@sanofi.com |
Sally BainTel: +1
617-834-6026Sally.Bain@sanofi.com |
Felix LauscherTel: +1
908-612-7239Felix.Lauscher@sanofi.com |
|
Tarik ElgoutniTel: +1
617-710-3587Tarik.Elgoutni@sanofi.com |
|
Nathalie PhamTel: +33 (0)7 85 93 30
17Nathalie.Pham@sanofi.com |
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