PARIS and TARRYTOWN, N.Y., Oct.
19, 2018 /PRNewswire/ -- Sanofi (EURONEXT: SAN) (NYSE:
SNY)
The U.S. Food and Drug Administration has approved
Dupixent® (dupilumab) as an add-on maintenance therapy
in patients with moderate-to-severe asthma aged 12 years and older
with an eosinophilic phenotype or with oral
corticosteroid-dependent asthma.
Dupixent inhibits the overactive signaling of interleukin-4
(IL-4) and interleukin-13 (IL-13), two key proteins that contribute
to the Type 2 inflammation that may underlie moderate-to-severe
asthma. This effect is associated with the reduction of
inflammatory biomarkers including fractional exhaled nitric oxide
(FeNO), immunoglobulin E (IgE) and eotaxin-3 (CCL26).
"Dupixent is now approved in
the U.S. for two important groups of uncontrolled asthma patients –
those who are moderate-to-severe with an eosinophilic phenotype or
those with oral corticosteroid-dependent asthma," said George D. Yancopoulos, M.D., Ph.D., President
and Chief Scientific Officer of Regeneron. "In the asthma clinical
trial program, Dupixent reduced severe exacerbations and oral
corticosteroid use, improved quality of life and showed
statistically significant and clinically meaningful improvements in
lung function. Following the approvals in atopic dermatitis and
asthma, and recently announced positive Phase 3 results in chronic
rhinosinusitis with nasal polyps, we are committed to advancing our
broad development program in additional Type 2 inflammatory
diseases."
"Today's approval marks a
significant development for certain people with moderate-to-severe
asthma aged 12 years and older. For patients dependent on oral
corticosteroids, Dupixent improved lung function, reduced oral
corticosteroid use and reduced exacerbations regardless of baseline
eosinophil levels," said Olivier
Brandicourt, M.D., Chief Executive Officer, Sanofi. "Despite
the spectrum of treatments for asthma, there continues to be an
unmet need for so many patients with moderate-to-severe asthma, and
given that Dupixent works differently than other biologics, there
is now a new treatment option for some of these patients.
Dupixent has already made a difference for many adults with atopic
dermatitis, and we now have the opportunity to do the same for
certain adults and adolescents with moderate-to severe asthma in
the U.S."
Patients with moderate-to-severe asthma often have uncontrolled,
persistent symptoms despite standard-of-care therapy that may make
them suitable for treatment with a biologic therapy. They live with
coughing, wheezing and difficulty breathing, and are at risk of
severe asthma attacks that may require emergency room visits or
hospitalizations.1,2 Oral corticosteroids can provide
relief for severe, short-term symptoms. However, their chronic use
is limited to the most severe patients due to the potential for
serious side effects.3,4
"Despite being compliant with
their current medicine, many people with moderate-to-severe asthma,
including those with eosinophilic phenotype or with oral steroid
dependence, live with persistent symptoms like unpredictable
attacks and difficulty breathing," said Kenneth Mendez, President and CEO of the Asthma
and Allergy Foundation of America (AAFA). "AAFA supports the
availability of innovative new treatment options for people with
asthma who struggle with uncontrolled symptoms that impair their
quality of life."
For people with asthma, Dupixent comes in two
doses (200 mg and 300 mg) given every other week at different
injection sites after an initial loading dose.
Efficacy and safety results from the pivotal clinical trial
program
The pivotal trial program evaluated 2,888 adult and adolescent
patients with moderate-to-severe asthma in three randomized,
placebo-controlled, multicenter trials (Trial 1, Trial 2 and Trial
3) for six months to one year (24 to 52 weeks). All trials enrolled
patients irrespective of minimum baseline eosinophil levels.
In Trial 2 (the largest trial), Dupixent reduced exacerbations
and improved lung function in the overall population. Benefits in
exacerbations were seen in patients with eosinophil counts greater
than or equal to 150 cells/microliter, which represented 70% of the
patients enrolled. Efficacy improved in patients with higher
eosinophil counts. For example, in patients with blood eosinophils
of 300 cells/microliter or greater, Dupixent reduced severe
exacerbations by 67% compared to placebo and improved
FEV1 (lung function) by 29%-33% compared to 14%-16% for
placebo. In patients with eosinophil counts less than 150
cells/microliter, there was no difference in severe exacerbation
rates for Dupixent versus placebo.
In Trial 3, which evaluated severe, oral
corticosteroid-dependent patients, Dupixent reduced average daily
oral corticosteroid use by 70% compared to 42% with placebo.
More than half of patients treated with Dupixent completely
eliminated use of oral corticosteroids. Effects on lung
function and on oral steroid and exacerbation reduction were
similar for Dupixent irrespective of baseline blood eosinophil
levels.
In the asthma clinical trials, the adverse reactions that
occurred with Dupixent at a rate of at least 1% and more frequently
than the respective comparator were injection site reactions, sore
throat, and an increase in the number of eosinophils, a type of
white blood cell, in the blood.
Additional data can be found in the prescribing information.
Data from Trial 1 were published in The Lancet in
April 2016 and data from Trials 2 and
3 were published in the New England Journal of Medicine in
May 2018.
About Dupixent
Dupixent comes in a pre-filled syringe and is intended for
injection under the skin (subcutaneous injection) under the
guidance of a healthcare provider. It can be given in a clinic or,
for convenience, at home by self-administration after training by a
healthcare professional.
Dupixent is also approved in the U.S. for the treatment of
adults with moderate-to-severe atopic dermatitis whose disease is
not adequately controlled with topical prescription therapies, or
when those therapies are not advisable. In the U.S., Dupixent is
marketed by Sanofi Genzyme, the specialty care global business unit
of Sanofi, and Regeneron.
The wholesale acquisition cost of Dupixent remains unchanged and
will be the same for both asthma doses. 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.
Dupixent is currently under regulatory review for
moderate-to-severe asthma in several other countries, including
Japan and in the European Union
(EU).
Dupilumab development program is ongoing
Sanofi and Regeneron are also studying dupilumab in a broad
range of clinical development programs for diseases driven by Type
2 inflammation, including chronic rhinosinusitis with nasal polyps
(Phase 3), pediatric asthma (Phase 3), pediatric atopic dermatitis
(Phase 3), adolescent atopic dermatitis (Phase 3), eosinophilic
esophagitis (Phase 3), grass allergy (Phase 2) and peanut allergy
(Phase 2). A future trial is planned for chronic obstructive
pulmonary disease. Dupixent is also being studied in combination
with REGN-3500, which targets IL-33. These potential uses are
investigational and the safety and efficacy have not been evaluated
by any regulatory authority. Dupilumab and REGN-3500 are being
jointly developed by Sanofi and Regeneron under a global
collaboration agreement.
For more information on dupilumab clinical trials please visit
www.clinicaltrials.gov.
IMPORTANT SAFETY INFORMATION AND INDICATIONS 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 (if you also have atopic dermatitis)
- 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. If you have atopic dermatitis, tell your
healthcare provider if you have any new or worsening eye problems,
including eye pain or changes in vision.
- Inflammation in your blood vessels: Rarely, this can
happen in people with asthma who receive DUPIXENT. This usually,
but not always, happens in people who also take a steroid medicine
by mouth that is being stopped or the dose is being lowered. 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 injection site
reaction, pain in the throat (oropharyngeal pain) and cold sores in
your mouth or on your lips. Eye and eyelid inflammation,
including redness, swelling and itching have been seen in patients
who have atopic dermatitis.
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. 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 adolescents with asthma 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.
INDICATIONS
DUPIXENT is a prescription medicine used:
- to treat adults 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 18 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.
About Regeneron
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
Regeneron Media
Relations Contact
Sarah
Cornhill
Tel: +1
914-847-5018 Sarah.Cornhill@regeneron.com
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Sanofi Investor
Relations Contact
George
Grofik
Tel: +33 (0)1 53 77
45 45
ir@sanofi.com
Regeneron Investor
Relations Contact
Manisha Narasimhan,
Ph.D.
Tel: +1
914-847-5126 Manisha.narasimhan@regeneron.com
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forward-looking statements that involve risks and uncertainties
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1 Global Initiative for Asthma (GINA). Global
Strategy for Asthma Management and Prevention. 2018. Available at:
http://ginasthma.org/download/832/. Last accessed July 2018.
2 Price D, Fletcher M, van der Molen T. Asthma control
and management in 8,000 European patients: the REcognise Asthma and
LInk to Symptoms and Experience (REALISE) survey. NPJ Prim Care
Respir Med 2014;24:14009.
3 Daugherty J et al. The impact of long-term systemic
glucocorticoid use in severe asthma: A UK retrospective cohort
analysis. J Asthma. 2017 Sep 19:1-8.
4 Lefebvre et al. Burden of systemic
glucocorticoid-related complications in severe asthma. Curr Med Res
Opin. 2017 Jan;33(1):57-65.
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