Nearly three times as many Dupixent patients experienced
clinically meaningful reductions in itch and skin lesions at 24
weeks compared to placebo
There are currently no approved medicines specifically
indicated to treat prurigo nodularis; regulatory
submissions for Dupixent are under Priority Review in the U.S. and
under review in the European Union
22 Dupixent abstracts are being presented at the EADV 2022
Congress across four dermatological diseases with underlying type 2
inflammation
TARRYTOWN, N.Y. and PARIS, Sept. 8,
2022 /PRNewswire/ -- Regeneron Pharmaceuticals, Inc.
(NASDAQ: REGN) and Sanofi today presented detailed positive results
from the second of two Phase 3 trials (PRIME) evaluating
Dupixent® (dupilumab) in adults with uncontrolled
prurigo nodularis in a late-breaking session at the European
Academy of Dermatology and Venereology (EADV) 2022 Congress. These
data, which were consistent with the detailed data from the first
Phase 3 trial (PRIME2) in prurigo nodularis, show Dupixent
significantly reduced itch and skin lesions at 24 weeks.
In total, 22 scientific abstracts are being presented at the
EADV 2022 Congress discussing Dupixent in atopic dermatitis in
patients as young as six months, and its investigational use in
chronic spontaneous urticaria and bullous pemphigoid, in addition
to prurigo nodularis.
"These positive results from the second of two dupilumab Phase 3
trials in prurigo nodularis confirm inhibiting IL-4 and IL-13 can
significantly reduce the unrelenting itch and extensive severe skin
lesions that often impair patient quality of life," said Gil
Yosipovitch, M.D., Professor of Dermatology at the Miller School of
Medicine at University of Miami,
Director of the Miami Itch Center and principal investigator of the
trial. "In my practice, relieving itch and clearing skin are often
the top priorities for my patients across a range of chronic skin
diseases. These data demonstrate dupilumab has the potential to
address and manage these debilitating symptoms in another chronic
skin disease with underlying type 2 inflammation."
The late-breaking data presented at the EADV 2022 Congress are
from the randomized, placebo-controlled Phase 3 PRIME trial,
which met its primary and key secondary endpoints. At 24 weeks,
among patients treated with Dupixent in the trial:
- More than three times as many (60%) experienced a clinically
meaningful reduction in itch from baseline, the primary endpoint,
compared to placebo patients (18%; p<0.0001).
- Nearly three times as many (48%) achieved clear or almost clear
skin, a key secondary endpoint, compared to placebo patients (18%;
p=0.0004).
The safety results of the trial were generally consistent with
the known safety profile of Dupixent in its approved dermatological
indication. For the 24-week treatment period, overall rates of
adverse events (AEs) were 71% for Dupixent and 63% for placebo. AEs
most commonly observed with Dupixent (≥5%) included nasopharyngitis
(5% Dupixent, 4% placebo) and headache (5% Dupixent, 5% placebo).
The rate of treatment discontinuation due to AEs prior to week 24
was 0% for Dupixent compared to 4% for placebo. A numerically lower
rate of skin infections was observed with Dupixent (4% Dupixent, 9%
placebo).
Results from this and an earlier Phase 3 trial, PRIME2, will
form the basis of regulatory submissions around the world for
Dupixent in prurigo nodularis this year. Regulatory submissions are
already under review by the European Commission and the U.S. Food
and Drug Administration (FDA), with the FDA granting Priority
Review in May 2022 and a target
action date of September 30,
2022.
The potential uses of Dupixent in prurigo nodularis, chronic
spontaneous urticaria and bullous pemphigoid are currently under
clinical development, and the safety and efficacy have not been
fully evaluated by any regulatory authority.
About Prurigo Nodularis
People with prurigo nodularis
experience intense, persistent itch, with thick skin lesions
(called nodules) that can cover most of the body. Prurigo nodularis
is often described as painful with burning, stinging and tingling
of the skin. The impact of uncontrolled prurigo nodularis on
quality of life is one of the highest among inflammatory skin
diseases due to the extreme itch and comparable to other
debilitating chronic diseases that can negatively affect mental
health, activities of daily living and social interactions.
High-potency topical steroids are commonly prescribed but are
associated with safety risks if used long-term.
About the Trial
PRIME, part of the LIBERTY-PN PRIME
clinical program, was a randomized, Phase 3, double-blind,
placebo-controlled trial that evaluated the efficacy and safety of
Dupixent in 151 adults with uncontrolled prurigo nodularis. These
included patients who were inadequately controlled with topical
prescription therapies or for whom those therapies were not
advisable. During the 24-week treatment period, patients received
Dupixent or placebo every two weeks with or without topical
treatments (low- or medium-dose topical corticosteroids or topical
calcineurin inhibitors were continued if patients were using these
treatments at randomization).
The primary endpoint evaluated the proportion of patients with
clinically meaningful improvement in itch at 24 weeks (measured by
a ≥4-point reduction in Worst-Itch Numeric Rating Scale [WI-NRS] of
0-10). A key secondary endpoint was the proportion of patients with
clear or almost clear skin at 24 weeks (measured by a score of 0 or
1 on the Investigator's Global Assessment PN-Stage [IGA PN-S] 0-4
scale).
About Dupixent
Dupixent, 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 asthma,
atopic dermatitis, chronic rhinosinusitis with nasal polyposis
(CRSwNP) and eosinophilic esophagitis (EoE), as well as
investigational diseases such as prurigo nodularis.
Dupixent has received regulatory approvals around the world for
use in certain patients with atopic dermatitis, asthma, CRSwNP or
EoE in different age populations. Dupixent is currently approved
across these indications in the U.S. and for one or more of these
indications in more than 60 countries, including in the European
Union and Japan. More than 500,000
patients have been treated with Dupixent globally.
About Regeneron's VelocImmune
Technology
Regeneron'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
approximately one in five 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 Program
Dupilumab 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 prurigo nodularis, pediatric eosinophilic
esophagitis, hand and foot atopic dermatitis, chronic inducible
urticaria-cold, chronic spontaneous urticaria, chronic pruritis of
unknown origin, chronic obstructive pulmonary disease with evidence
of type 2 inflammation, chronic rhinosinusitis without nasal
polyposis, allergic fungal rhinosinusitis, allergic
bronchopulmonary aspergillosis 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 atopic dermatitis (eczema) 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).
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,
CRSwNP, or EoE, 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:
- Atopic dermatitis: 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, pain in the throat
(oropharyngeal pain), high count of a certain white blood cell
(eosinophilia), 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), trouble sleeping (insomnia), toothache, gastritis,
and joint pain (arthralgia).
- Eosinophilic esophagitis: injection site reactions,
upper respiratory tract infections, cold sores in your mouth or on
your lips, and joint pain (arthralgia).
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 under 12 years of age, DUPIXENT should be given
by a caregiver.
Please see accompanying full Prescribing Information including Patient Information.
About Regeneron
Regeneron is a leading biotechnology company that invents, develops
and commercializes life-transforming medicines for people with
serious diseases. Founded and led for nearly 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, pain, 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, please visit www.Regeneron.com or
follow @Regeneron on Twitter.
About Sanofi
We 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 impact of SARS-CoV-2 (the virus that has
caused the COVID-19 pandemic) on Regeneron's business and its
employees, collaborators, and suppliers and other third parties on
which Regeneron relies, Regeneron's and its collaborators' ability
to continue to conduct research and clinical programs, Regeneron's
ability to manage its supply chain, net product sales of products
marketed or otherwise commercialized by Regeneron and/or its
collaborators or licensees (collectively, "Regeneron's Products"),
and the global economy; the nature, timing, and possible success
and therapeutic applications of 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) for the treatment of
prurigo nodularis; 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 prurigo nodularis (including
potential approval by the U.S. Food and Drug Administration and/or
the European Commission as discussed in this press release), hand
and foot atopic dermatitis, chronic obstructive pulmonary disease
with evidence of type 2 inflammation, pediatric eosinophilic
esophagitis, bullous pemphigoid, chronic spontaneous urticaria,
chronic pruritis of unknown origin, chronic inducible
urticaria-cold, chronic rhinosinusitis without nasal polyposis,
allergic fungal rhinosinusitis, allergic bronchopulmonary
aspergillosis, and other potential indications; 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 (such as Dupixent) and Regeneron's Product
Candidates; the ability of Regeneron's collaborators, 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
Products and Regeneron's Product Candidates, including without
limitation Dupixent; 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 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 or collaboration agreement,
including Regeneron's agreements with Sanofi, Bayer, and Teva
Pharmaceutical Industries Ltd. (or their respective affiliated
companies, as applicable), to be cancelled or terminated; 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, Dupixent, Praluent® (alirocumab),
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
fiscal year ended December 31, 2021
and its Form 10-Q for the quarterly period ended June 30, 2022. 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 (http://newsroom.regeneron.com) and its
Twitter feed (http://twitter.com/regeneron).
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 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 COVID-19 will 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. Any material effect of COVID-19 on any of the
foregoing could also adversely impact us. This situation is
changing rapidly and additional impacts may arise of which we are
not currently aware and may exacerbate other previously identified
risks. 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
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applicable law, Sanofi does not undertake any obligation to update
or revise any forward-looking information or statements.
Regeneron
Contacts:
Media
Relations
Hannah
Kwagh
Tel: +1
914-847-6314
Hannah.Kwagh@regeneron.com
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Investor
Relations
Vesna
Tosic
Tel: +1
914-847-5443
Vesna.Tosic@regeneron.com
|
|
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Sanofi
Contacts:
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Media
Relations
Sally
Bain
Tel: +1
617-834-6026
Sally.Bain@sanofi.com
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Investor
Relations
Eva
Schaefer-Jansen
Tel: +33 7 86 80 56
39
eva.schaefer-jansen@sanofi.com
Arnaud
Delepine
Tel: +33 (0)6 73 69 36
93
arnaud.delepine@sanofi.com
Corentine
Driancourt
Tel: +33 (0)6 40 56
92
corentine.driancourt@sanofi.com
Felix
Lauscher
Tel: +1
908-612-7239
felix.lauscher@sanofi.com
Priya
Nanduri
Tel: +1
617-764-6418
priya.nanduri@sanofi.com
Nathalie
Pham
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17
nathalie.pham@sanofi.com
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