PARIS and TARRYTOWN, N.Y., June
26, 2019 /PRNewswire/ -- The U.S. Food and Drug
Administration (FDA) has approved Dupixent® (dupilumab)
for use with other medicines to treat chronic rhinosinusitis with
nasal polyposis (CRSwNP) in adults whose disease is not controlled.
CRSwNP can be a debilitating condition, with many patients opting
for systemic steroids or nasal surgery which often cannot control
this disease. Moreover, CRSwNP often occurs in combination with
severe asthma.
"Dupixent is the first FDA
approved medicine for adults with chronic rhinosinusitis with nasal
polyposis, and the only approved therapy shown to shrink nasal
polyp size and also improve the signs and symptoms of the
associated chronic rhinosinusitis. In fact, approximately
three-quarters of patients treated with Dupixent no longer required
either corticosteroids or surgery, the current standards of
care," said George D.
Yancopoulos, M.D., Ph.D., President and Chief Scientific
Officer at Regeneron. "Importantly, many patients with CRSwNP
also suffer from asthma, and Dupixent was shown to improve lung
function in these patients as well. This approval further
reinforces that IL-4 and IL-13 are key drivers of type 2
inflammation, and we continue to study Dupixent in other type 2
inflammatory diseases, including eosinophilic esophagitis, and food
and environmental allergies."
The FDA evaluated the CRSwNP Dupixent application under Priority
Review, which is reserved for medicines that represent potentially
significant improvements in efficacy or safety in treating serious
conditions.
Dupixent is a fully-human monoclonal antibody that inhibits the
signalling of interleukin-4 (IL-4) and interleukin-13 (IL-13), two
proteins that play a central role in type 2 inflammation. Data from
Dupixent clinical trials have shown that inhibiting IL-4 and IL-13
helps address the type 2 inflammation that plays a major role in
CRSwNP, asthma and atopic dermatitis.
"Chronic rhinosinusitis
with nasal polyposis can be a debilitating condition.
Today's standard of care – which includes intranasal and
systemic corticosteroids and sinus surgery – often leaves patients
with CRSwNP with recurring symptoms," said John Reed, M.D., Ph.D., Head of Research and
Development at Sanofi. "In two Phase 3 trials, Dupixent helped
patients significantly reduce their nasal congestion, and many
patients experienced significant improvement in their sense of
smell in as quickly as four weeks. Treatment with Dupixent also
reduced the need for systemic steroids and surgery, and led to
improvements in health-related quality of life. Importantly, these
patients with co-morbid asthma now have a treatment that can help
improve their breathing."
CRSwNP is a chronic disease of the upper airway that obstructs
the sinuses and nasal passages. It can lead to breathing
difficulties, nasal congestion and discharge, reduced or loss of
sense of smell and taste, and facial pressure. Many patients with
CRSwNP have other type 2 inflammatory diseases like asthma, and
these patients often have more severe asthma and are often more
difficult to treat. In the Dupixent CRSwNP clinical trials, 59% of
patients also had asthma. These co-morbid diseases can lead to an
increased risk of asthma attacks, high symptom burden and a
substantial adverse impact on health-related quality of life.
Efficacy and safety from pivotal clinical trials
The FDA approval is based on two pivotal trials (the 24-week
SINUS-24 and 52-week SINUS-52) that are part of the Phase 3 LIBERTY
clinical trial program. These trials evaluated Dupixent 300 mg
every two weeks with standard-of-care mometasone furoate nasal
spray (MFNS) compared to placebo injection plus MFNS. In these
trials, Dupixent significantly improved key disease measures and
met all primary and secondary endpoints. At 24 weeks, patients
treated with Dupixent achieved statistically significant
improvements in all primary and secondary endpoints, including:
- Co-primary endpoints:
-
- 57% and 51% improvement in their nasal congestion/obstruction
severity compared to a 19% and 15% improvement with placebo in
SINUS-24 and SINUS-52, respectively (least squares [LS] mean change
from baseline of -1.34 and -1.25 for Dupixent compared to
-0.45 and -0.38 for placebo; difference between Dupixent and
placebo: -0.89 and -0.87).
- 33% and 27% reduction in their nasal polyps score compared to a
7% and 4% increase with placebo in SINUS-24 and SINUS-52,
respectively (LS mean change from baseline of -1.89 and -1.71 for
Dupixent compared to 0.17 and 0.10 for placebo; difference between
Dupixent and placebo: -2.06 and -1.80).
- Secondary endpoints include:
-
- 42% and 27% improvement in sinus opacification compared to 4%
and 0% with placebo in SINUS-24 and SINUS-52, respectively (LS mean
change from baseline of -8.18 and -5.21 for Dupixent compared to
-0.74 and -0.09 for placebo).
- 52% and 45% improvement in loss of smell compared to a 12% and
10% improvement with placebo in SINUS-24 and SINUS-52, respectively
(LS mean difference in Dupixent compared to placebo of -1.12 and
-0.98 in SINUS-24 and SINUS-52, respectively).
In pre-specified pooled analyses of the two trials up to 52
weeks, Dupixent treatment resulted in a significant reduction of
systemic corticosteroid use and the need for sino‑nasal surgery
compared to placebo.
- The proportion of patients who required systemic
corticosteroids was reduced by 74% with Dupixent compared to
placebo.
- The proportion of patients who required sino-nasal surgery was
reduced by 83% with Dupixent compared to placebo.
In the 59% of patients who also had asthma, the improvements in
lung function were similar to patients in the Dupixent asthma
program.
Treatment effects on nasal congestion and loss of smell were
observed with the first assessment as early as 4 weeks and showed
continued improvement for the duration of the trial. In the
52 week SINUS-52 trial, patients continued to do well through the
52 week treatment period.
In the CRSwNP clinical trials, adverse events that occurred in
at least 2% of Dupixent patients and greater than placebo were
injection site reactions (6% Dupixent, 4% placebo), conjunctivitis
(2% Dupixent, 1% placebo), arthralgia (3% Dupixent, 2% placebo) and
gastritis (2% Dupixent, 1% placebo).
Another indication for Dupixent
Dupixent comes in a 300 mg pre-filled syringe for patients with
CRSwNP. It is given as a subcutaneous injection every other week at
different injection sites. Dupixent is intended for use under the
guidance of a healthcare professional and can be given in a clinic
or at home by self-administration after training by a healthcare
professional.
In addition to CRSwNP, Dupixent is approved in the U.S. for use
with other asthma medicines for the maintenance treatment of
moderate-to-severe asthma in certain patients aged 12 years and
older whose asthma is not controlled with their current asthma
medicines; and to treat patients aged 12 years 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.
The wholesale acquisition cost of Dupixent remains unchanged
with the addition of this indication. Sanofi and Regeneron are
committed to helping patients in the U.S. who are prescribed
Dupixent gain access to the medicine and receive the support they
may need with the DUPIXENT MyWay® program. For more
information, please call 1-844-DUPIXENT (1-844-387-4936) or visit
www.DUPIXENT.com.
Outside of the U.S., Dupixent is approved in a number of
countries for use in certain adults with moderate-to-severe atopic
dermatitis. Dupixent is also approved in a number of other
countries, including those in the European Union (EU), Japan and Australia, to treat certain patients aged 12
years and older with severe asthma. Dupixent is currently under
regulatory review for patients with CRSwNP in the EU, and for
adolescents with moderate-to-severe atopic dermatitis in several
countries, including Japan, and in
the EU.
Dupilumab development program
In addition to the currently approved indications, Sanofi and
Regeneron are also studying dupilumab in a broad range of clinical
development programs for diseases driven by allergic and other type
2 inflammation, including pediatric asthma and atopic dermatitis (6
to 11 years of age, Phase 3), pediatric atopic dermatitis (6 months
to 5 years of age, Phase 2/3), eosinophilic esophagitis (Phase 3),
chronic obstructive pulmonary disease (Phase 3), and food and
environmental allergies (Phase 2). Dupilumab is also being studied
in combination with REGN3500 (SAR440340), which targets IL-33. These potential
uses are investigational and the safety and efficacy have not been
evaluated by any regulatory authority. Dupilumab is being
jointly developed by Sanofi and Regeneron under a global
collaboration agreement.
U.S. INDICATIONS
DUPIXENT is a prescription medicine used:
- to treat people 12 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 12
years of age.
- with other asthma medicines for the maintenance treatment of
moderate-to-severe asthma in people aged 12 years 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 12 years of
age.
- with other medicines to treat chronic rhinosinusitis with nasal
polyposis 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 taking oral, topical, or inhaled corticosteroid medicines.
Do not stop taking your corticosteroid medicines unless
instructed by your healthcare provider. This may cause other
symptoms that were controlled by the corticosteroid medicine to
come back.
- are scheduled to receive any vaccinations. You should not
receive a "live vaccine" if you are treated with DUPIXENT.
- are pregnant or plan to become pregnant. It is not known
whether DUPIXENT will harm your unborn baby.
- 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. If you are taking asthma medicines, do not
change or stop your asthma medicine without talking to your
healthcare provider.
DUPIXENT can cause serious side effects,
including:
- Allergic reactions (hypersensitivity), including a severe
reaction known as anaphylaxis. Stop using DUPIXENT and tell
your healthcare provider or get emergency help right away if you
get any of the following symptoms: breathing problems, fever,
general ill feeling, swollen lymph nodes, swelling of the face,
mouth and tongue, hives, itching, fainting, dizziness, feeling
lightheaded (low blood pressure), joint pain, or skin rash.
- Eye problems. Tell your healthcare provider if you have
any new or worsening eye problems, including eye pain or changes in
vision.
- 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, shortness of breath, persistent fever, chest pain,
or a feeling of pins and needles or numbness of your arms or
legs.
The most common side effects include:
- Atopic dermatitis: injection site reactions, eye and
eyelid inflammation, including redness, swelling, and itching, and
cold sores in your mouth or on your lips.
- Asthma: injection site reactions, pain in the throat
(oropharyngeal pain), and high count of a certain white blood cell
(eosinophilia).
- Chronic rhinosinusitis with nasal polyposis: injection
site reactions, eye and eyelid inflammation, including redness,
swelling, and itching, 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. DUPIXENT is an injection
given under the skin (subcutaneous injection). If your healthcare
provider decides that you or a caregiver can give DUPIXENT
injections, you or your caregiver should receive training on the
right way to prepare and inject DUPIXENT. Do not try to
inject DUPIXENT until you have been shown the right way by your
healthcare provider. In children 12 years of age and older, it is
recommended that DUPIXENT be administered by or under supervision
of an adult.
Please see accompanying full Prescribing
Information including Patient Information.
About Regeneron Pharmaceuticals, Inc.
Regeneron (NASDAQ: REGN) is a leading biotechnology company that
invents life-transforming medicines for people with serious
diseases. Founded and led for 30 years by physician-scientists, our
unique ability to repeatedly and consistently translate science
into medicine has led to seven FDA-approved treatments and numerous
product candidates in development, 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, neuromuscular
diseases, infectious diseases and rare diseases.
Regeneron is accelerating and improving the traditional drug
development process through our proprietary VelociSuite®
technologies, such as VelocImmune® which produces optimized
fully-human antibodies, and 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
Sanofi is dedicated to supporting people through their health
challenges. We are a global biopharmaceutical company focused on
human health. We prevent illness with vaccines, provide innovative
treatments to fight pain and ease suffering. We stand by the few
who suffer from rare diseases and the millions with long-term
chronic conditions.
With more than 100,000 people in 100 countries, Sanofi is
transforming scientific innovation into healthcare solutions around
the globe.
Sanofi, Empowering Life
Sanofi Media
Relations Contact Ashleigh
Koss Tel: +1 (908)
981-8745 Ashleigh.Koss@sanofi.com
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ir@sanofi.com
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Regeneron Media
Relations Contact Sharon
Chen Tel: +1 (914)
847-1546 Sharon.Chen@regeneron.com
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Regeneron Investor
Relations Contact Mark
Hudson Tel: +1 (914)
847-3482 Mark.Hudson@regeneron.com
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Forward-Looking Statements and Use of Digital
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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
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Injection, Dupixent, and Praluent® (alirocumab) Injection, the
ultimate outcome of any such proceedings, and the impact any of the
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