TARRYTOWN, N.Y. and PARIS, March 26,
2022 /PRNewswire/ --
Dupixent significantly reduced itch at 12 weeks,
and at 24 weeks nearly three times as many
Dupixent patients experienced clinically meaningful reductions in
itch and skin lesions
There are currently no approved systemic treatments for
prurigo nodularis; regulatory filings for Dupixent in prurigo
nodularis are planned in the first half of 2022
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi
announced that detailed positive results from the Phase 3 PRIME2
trial evaluating the efficacy and safety of Dupixent®
(dupilumab) were presented today in a late-breaking session at
the American Academy of Dermatology (AAD) 2022 Annual Meeting. The
companies previously announced topline results from PRIME2 and
a second trial, called PRIME, investigating the use of Dupixent in
adults with uncontrolled prurigo nodularis. In both trials,
Dupixent significantly reduced itch and skin lesions compared
to placebo. In total, 21 scientific abstracts evaluating the safety
and efficacy of Dupixent in patients with atopic dermatitis in
different age groups, as well as investigational indications of
prurigo nodularis and chronic spontaneous urticaria will be
presented at the congress.
"Prurigo nodularis is a relentless and often misunderstood itchy
skin disease that leaves many patients with uncontrolled symptoms
such as unbearable itch and painful skin lesions, along with a
significantly impaired quality of life that should not be
underestimated," 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. "These positive
results are the first time a Phase 3 trial has demonstrated that
targeting key drivers of type 2 inflammation, IL-4 and IL-13, with
dupilumab significantly improved itch and skin lesions in this
highly burdensome disease."
The randomized, placebo-controlled PRIME2 trial met its primary
and all key secondary endpoints, with data presented at AAD 2022
showing:
- 37% of Dupixent patients experienced a clinically meaningful
reduction in itch from baseline compared to 22% of placebo patients
(p=0.0216) at week 12, the primary endpoint.
- Nearly three times as many Dupixent patients experienced a
clinically meaningful reduction in itch from baseline at week 24:
58% of Dupixent patients compared to 20% of placebo patients
(p<0.0001).
- Nearly three times as many Dupixent patients achieved clear or
almost clear skin at week 24: 45% of Dupixent patients compared to
16% of placebo patients (p<0.0001).
The safety results of the trial were generally consistent with
the known safety profile of Dupixent in its approved dermatology
indications. For the 24-week treatment period, overall rates of
adverse events were generally similar between Dupixent and placebo
groups (57% Dupixent, 51% placebo). Adverse events that were more
commonly (≥5%) observed with Dupixent were herpes viral infections
(7% Dupixent, 0% placebo). A lower rate of skin infections was
observed with Dupixent (5% Dupixent, 9% placebo). Additionally, 3%
of Dupixent patients and 30% of placebo patients discontinued prior
to week 24.
Results from the confirmatory PRIME trial will be presented at
an upcoming medical congress. Data from both trials will form the
basis of regulatory submissions around the world for Dupixent in
prurigo nodularis, which are planned to begin in the first half of
2022.
The potential use of Dupixent in prurigo nodularis is 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 is 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. There are
approximately 75,000 people in the U.S. who are unable to control
their disease with systemic therapy and are most in need of a
treatment option.
About the Trial
PRIME2, part of the LIBERTY-PN PRIME
clinical program, is a randomized, Phase 3, double-blind,
placebo-controlled trial that evaluated the efficacy and safety of
Dupixent in 160 adults with prurigo nodularis inadequately
controlled with topical prescription therapies or with 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 week 12 (measured by a
≥4-point reduction in Worst-Itch Numeric Rating Scale [WI-NRS] of
0-10). Key secondary endpoints included the proportion of patients
with clinically meaningful improvement in itch at week 24 and the
proportion of patients with clear or almost clear skin at week 24
(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. IL-4 and IL-13 are key and central
drivers of the type 2 inflammation that plays a major role in
atopic dermatitis, asthma and chronic rhinosinusitis with nasal
polyposis (CRSwNP).
Dupixent is currently approved in the U.S., Europe, Japan
and other countries around the world for use in specific patients
with moderate-to-severe atopic dermatitis, as well as certain
patients with asthma or CRSwNP in different age populations.
Dupixent is also approved in one or more of these indications in
more than 60 countries around the world and more than 400,000
patients have been treated 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 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 a quarter of all original, FDA-approved or authorized
fully human monoclonal antibodies currently available. This
includes Dupixent, REGEN-COV® (casirivimab and
imdevimab), 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, including
prurigo nodularis (Phase 3), pediatric atopic dermatitis (6 months
to 5 years of age, Phase 3), hand and foot atopic dermatitis (Phase
3), eosinophilic esophagitis (Phase 3), chronic spontaneous
urticaria (Phase 3), bullous pemphigoid (Phase 3), chronic
inducible urticaria-cold (Phase 3), chronic obstructive pulmonary
disease with evidence of type 2 inflammation (Phase 3), chronic
rhinosinusitis without nasal polyposis (Phase 3), allergic fungal
rhinosinusitis (Phase 3), allergic bronchopulmonary aspergillosis
(Phase 3) and peanut allergy (Phase 2). 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 years 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 years
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.
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 or CRSwNP, 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, and cold sores in your mouth or on
your lips.
- 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).
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 (NASDAQ: REGN) is a leading biotechnology company that
invents 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 nine
FDA-approved treatments and numerous 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 additional information about the company, 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, chronic obstructive pulmonary disease with evidence of
type 2 inflammation, pediatric atopic dermatitis, eosinophilic
esophagitis, bullous pemphigoid, chronic spontaneous urticaria,
chronic inducible urticaria-cold, chronic rhinosinusitis without
nasal polyposis, allergic fungal rhinosinusitis, allergic
bronchopulmonary aspergillosis, peanut allergy, 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, licensees, suppliers, or other third
parties (as applicable) to perform manufacturing, filling,
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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 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, 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 year
ended December 31, 2021. 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
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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
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Company, including information that may be deemed material to
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routinely posted and is accessible on Regeneron's media and
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Sanofi Disclaimers or Forward-Looking
Statements
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amended. Forward-looking statements are statements that are not
historical facts. These statements include projections and
estimates regarding the marketing and other potential of the
product, or regarding potential future revenues from the product.
Forward-looking statements are generally identified by the words
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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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Relations
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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
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Lauscher
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908-612-7239
felix.lauscher@sanofi.com
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Nanduri
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Pham
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17
nathalie.pham@sanofi.com
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SOURCE Regeneron Pharmaceuticals, Inc.