Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today
announced that the U.S. Food and Drug Administration (FDA) has
issued a Complete Response Letter (CRL) for the supplemental
Biologics License Application (sBLA) for Dupixent® (dupilumab) in
chronic spontaneous urticaria (CSU). CSU is an inflammatory skin
condition, which causes sudden and debilitating hives and swelling
on the skin. The CRL states that additional efficacy data are
required to support an approval; it did not identify any issues
with safety or manufacturing. An ongoing clinical trial (Study C)
continues to enroll patients, with results expected in late 2024
that are anticipated to provide the additional efficacy data.
Regeneron and Sanofi remain committed to working
with the FDA to advance the study of Dupixent for patients living
with CSU who are inadequately controlled by antihistamines.
The potential use of Dupixent in CSU is
currently under clinical development, and the safety and efficacy
have not been fully evaluated by any regulatory authority.
About the CSU Clinical Trial
ProgramThe clinical trial program, known as LIBERTY-CUPID,
includes Studies A, B and C, three Phase 3 randomized,
double-blind, placebo-controlled trials evaluating the efficacy and
safety of Dupixent in two different patient populations with
uncontrolled CSU.
Study A evaluated Dupixent as an add-on therapy
to standard-of-care H1 antihistamines compared to antihistamines
alone in 138 patients with CSU aged 6 years and older who remained
symptomatic despite antihistamine use and were not previously
treated with omalizumab. Efficacy and safety data from Study A were
the basis of the sBLA. Study B evaluated Dupixent in 108 patients
with CSU aged 12 to 80 years who remained symptomatic despite
standard-of-care treatment and were intolerant or incomplete
responders to omalizumab, with results providing additional
supporting data for the sBLA. Study C is an ongoing trial
investigating Dupixent in the same population as Study A.
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), prurigo nodularis and EoE.
Dupixent has received regulatory approvals in
one or more countries around the world for use in certain patients
with atopic dermatitis, asthma, CRSwNP, EoE or prurigo nodularis 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. More than 750,000 patients are being
treated with Dupixent globally.
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 pediatric EoE, 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 12 years of age and older, who
weigh at least 88 pounds (40 kg), with eosinophilic esophagitis
(EoE). It is not known if DUPIXENT is safe and effective in
children with eosinophilic esophagitis under 12 years of age and
who weigh at least 88 pounds (40 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 FOR U.S.
PATIENTS
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, 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 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. Regeneron’s 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 its
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 additional 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 Media This 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 chronic spontaneous
urticaria (“CSU”), including based on the supplemental Biologics
License Application discussed in this press release (the “Dupixent
CSU sBLA”)); the impact of the Complete Response Letter for the
Dupixent CSU sBLA discussed in this press release (the “CRL”) on
the timing of potential approval of Dupixent for the treatment of
CSU by the U.S. Food and Drug Administration (the “FDA”) and
whether and how timely Regeneron and Sanofi are able to resolve the
issues identified in the CRL; uncertainty of the utilization,
market acceptance, and commercial success of Regeneron’s Products
(such as Dupixent) 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 and
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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
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ability to continue to develop or commercialize Regeneron’s
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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 and REGEN-COV® (casirivimab and imdevimab)), 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, 2022 and its Form 10-Q for the
quarterly period ended June 30, 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 Statements This 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
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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
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competition in general, risks associated with intellectual property
and any related future litigation and the ultimate outcome of such
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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
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Regeneron
Contacts:Media RelationsTammy
AllenTel: +1 914-306-2698Tammy.Allen@regeneron.com |
Investor
RelationsVesna TosicTel: +1
914-847-5443Vesna.Tosic@regeneron.com |
Sanofi
Contacts:Media RelationsSally
BainTel: +1 617-834-6026Sally.Bain@sanofi.com |
Investor
RelationsEva Schaefer-JansenTel: +33 7 86
80 56 39Eva.Schaefer-Jansen@sanofi.comArnaud
DelepineTel: +33 (0)6 73 69 36
93Arnaud.Delepine@sanofi.comCorentine
DriancourtTel: +33 (0)6 40 56
92Corentine.Driancourt@sanofi.comFelix
LauscherTel: +1
908-612-7239Felix.Lauscher@sanofi.comTarik
ElgoutniTel: +1
617-710-3587Tarik.Elgoutni@sanofi.comNathalie
PhamTel: +33 (0)7 85 93 30 17Nathalie.Pham@sanofi.com |
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