(MENAFN- PR Newswire) Recommendation is based on data from two pivotal trials showing Dupixent significantly improved itch, skin lesions and health-related quality of life in adults with prurigo nodularis
If approved, Dupixent would be the first and only targeted medicine specifically indicated for prurigo nodularis in the European Union
TARRYTOWN, N.Y. and PARIS, Nov. 11, 2022 /PRNewswire/ -- Regeneron Pharmaceuticals, Inc. (NASDAQ: ) and Sanofi today announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion, recommending the approval of Dupixent® (dupilumab) in the European Union (EU) to treat adults with moderate-to-severe prurigo nodularis who are candidates for systemic therapy. The European Commission is expected to announce a final decision on the Dupixent application in the coming months. In September 2022, Dupixent was
by the U.S. Food and Drug Administration for the treatment of adult patients with prurigo nodularis.
Prurigo nodularis is a chronic, debilitating skin disease with underlying type 2 inflammation and has one of the highest impacts on a patient's quality of life among inflammatory skin diseases, due to the extreme itch it causes. Those with prurigo nodularis experience intense, persistent itch with thick skin lesions (called nodules) that can cover most of the body. The disease is often painful – with burning, stinging and tingling of the skin – and 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.
The positive CHMP opinion is supported by data from two Phase 3 trials,
and , showing Dupixent significantly reduced itch (the primary endpoint) and skin lesions compared to placebo. Dupixent also significantly improved health-related quality of life while reducing measures of skin pain and symptoms of anxiety/depression. The safety results of the trial were generally consistent with the known safety profile of Dupixent in its approved dermatology indication. Adverse events more commonly observed with Dupixent compared to placebo included conjunctivitis.
The use of Dupixent in adults with moderate-to-severe prurigo nodularis is investigational in the EU and is not yet approved.
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 atopic dermatitis, asthma and chronic rhinosinusitis with nasal polyposis (CRSwNP), as well as investigational diseases prurigo nodularis and eosinophilic esophagitis (EoE) in the EU.
Dupixent has received regulatory approvals in one or more countries around the world for use in certain patients with atopic dermatitis, prurigo nodularis, 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 EU 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
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 pediatric EoE, hand and foot atopic dermatitis, chronic inducible urticaria-cold, chronic spontaneous urticaria, chronic pruritus 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 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
Do
not
use if you
are
allergic
to
dupilumab
or
to
any
of the
ingredients
in
DUPIXENT®.
B e fore 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 .
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 :
All e r g i c
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. I n flammation
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.
T h e
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. C h r on i c
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 ,
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
i nc l ud i n g
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 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 more information, please visit 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 andNASDAQ:
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); the impact of the opinion adopted by the European Medicines Agency's Committee for Medicinal Products for Human Use discussed in this press release on potential approval by the European Commission of Dupixent to treat adults with moderate-to-severe prurigo nodularis and the timing of any such approval; 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 and Regeneron's Product Candidates; 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 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, bullous pemphigoidand, other potential indications; the ability of Regeneron's collaborators, licensees, suppliers, or other third parties (as applicable) to perform manufacturing, filling, finishing, packaging, labeling, distribution, and other steps related to Regeneron's Products and Regeneron's Product Candidates; the ability of Regeneron to manage supply chains for multiple products and product candidates; safety issues resulting from the administration of Regeneron's Products (such as Dupixent) and Regeneron's Product Candidates in patients, including serious complications or side effects in connection with the use of Regeneron's Products and Regeneron's Product Candidates in clinical trials; determinations by regulatory and administrative governmental authorities which may delay or restrict Regeneron's ability to continue to develop or commercialize Regeneron's 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 and Bayer (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, 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 and its Form 10-Q for the quarterly period ended September 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 ( ) and its Twitter feed ( ).
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| Regeneron Contacts: |
| |
| Media Relations Hannah Kwagh Tel: +1 914-847-6314 | Investor Relations Vesna Tosic Tel: +1 914-847-5443
|
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Sanofi Contacts:
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SOURCE Regeneron Pharmaceuticals, Inc.