PARIS and TARRYTOWN, N.Y., Oct.
16, 2018 /PRNewswire/ -- Two pivotal Phase 3
placebo-controlled trials evaluating Dupixent®
(dupilumab) in adults with inadequately-controlled chronic
rhinosinusitis with nasal polyps ("CRSwNP") met all primary and
secondary endpoints.
On the co-primary endpoints for both trials at 24 weeks,
patients treated with Dupixent added to a standard-of-care
corticosteroid nasal spray experienced a 51% and 57% improvement in
their nasal congestion/obstruction severity compared to 15% and 19%
improvement with nasal spray alone (placebo) (-1.25 and -1.34 for
Dupixent compared to -0.38 and -0.45 for placebo, on a 0-3 scale ).
Dupixent treated patients had a 27% and 33% reduction in
their nasal polyps score compared to a 4% and 7% increase for
placebo (-1.71 and -1.89 for Dupixent compared to 0.10 and 0.17 for
placebo, on a 0-8 scale that measures bilateral polyps size by
endoscopy).
Dupixent also met all secondary endpoints in both trials,
including demonstrating a significant reduction in the need for
systemic corticosteroids or surgery, and improvements in smell and
chronic rhinosinusitis symptoms. In a pre-specified group of
patients with comorbid asthma, Dupixent significantly improved lung
function and asthma control (p < 0.0001 for all primary and
secondary endpoints in both trials). Dupixent blocks the IL-4 and
IL-13 signaling pathways.
"Dupixent has now demonstrated
significant late-stage efficacy in three Type 2 or allergic
inflammatory diseases, indicating that IL-4 and IL-13 are
required drivers of Type 2 or allergic inflammation
in general. With these data, Dupixent has now been shown to
address this inflammation across the complete airway, which
manifests in the upper respiratory tract as polyps and congestion,
and in the lower airway as asthma," said George D. Yancopoulos, M.D., Ph.D., President
and Chief Scientific Officer of Regeneron. "We look forward to
U.S. regulatory action on our moderate-to-severe asthma application
later this month, and are continuing our development program in
additional Type 2 or allergic inflammatory diseases
with high unmet need including pediatric asthma, pediatric and
adolescent atopic dermatitis, eosinophilic esophagitis, and food
and environmental allergies."
CRSwNP is a chronic disease in which Type 2 or allergic
inflammation causes polyps that obstruct the sinus and nasal
passages, leading to severe congestion, nasal discharge, facial
pain or pressure, and reduced sense of smell and taste. Persistent
symptoms of CRSwNP have a substantial adverse impact on patients'
health-related quality of life. Current treatments are limited and
include intranasal corticosteroids, oral corticosteroids and
surgery, with high recurrence rates after treatment. Among the
patients involved in the two Phase 3 Dupixent trials, more than
half had previously undergone surgery for their nasal polyps and
nearly three-quarters had used systemic corticosteroids within the
past two years.
"Living with inadequately
controlled nasal polyps carries a heavy burden with patients
experiencing pain, nasal discharge, difficulty breathing and the
inability to smell. The standard of care, which includes the use of
oral and intranasal corticosteroids, often alongside surgery, has
not changed for decades," said John
Reed, M.D., Executive Vice President, Global Head of
Research & Development, Sanofi. "For the first time, we have
Phase 3 data showing that a biologic can help address the
underlying Type 2 or allergic inflammation that causes
chronic rhinosinusitis with nasal polyps and we look
forward to working with regulatory authorities around the world to
make Dupixent an option for people living with this chronic
condition."
The rates of adverse events were generally similar across
Dupixent and placebo, and no new or unexpected side effects related
to Dupixent were observed. The rates of conjunctivitis were: 1.4
percent Dupixent versus 0.8 percent placebo in SINUS-24; 2.7
percent Dupixent every two weeks and 2.0 percent Dupixent every
two/four weeks versus 1.3 percent placebo in SINUS-52. Overall
rates of serious adverse events were lower with Dupixent: 4.2
percent Dupixent versus 14.4 percent placebo in SINUS-24; 5.4
percent Dupixent every two weeks and 6.8 percent Dupixent every
two/four weeks versus 10.0 percent placebo in SINUS-52.
The pivotal Phase 3 trials, known as SINUS-24 (n=276) and
SINUS-52 (n=448), had the same co-primary endpoints, which were
change from baseline in nasal congestion/ obstruction severity
based on the patient's daily morning assessment, and change from
baseline in nasal polyposis score (a measure of polyp size) after
24 weeks, as assessed by nasal endoscopy. An additional co-primary
endpoint in Japan, a key secondary
endpoint in other countries, was change from baseline in sinus
opacification, as assessed by computed tomography scan. The trials
were randomized double-blind, placebo-controlled trials evaluating
Dupixent when added to the corticosteroid mometasone furoate nasal
spray (MFNS), compared to MFNS alone. The trials enrolled patients
who were 18 years or older with bilateral nasal polyps who, despite
treatment with systemic corticosteroids in the previous two years
or history of surgery, continued to have ongoing moderate or severe
symptoms of nasal congestion, blockage, loss of smell or nasal
discharge. Consistent with the overlap seen among patients with
Type 2 or allergic inflammatory diseases, more than three-quarters
also suffered from other conditions, including asthma
(approximately 59 percent), allergic rhinitis (approximately 58
percent) and NSAID-exacerbated respiratory disease (approximately
28 percent). Patients with co-morbid asthma and CRSwNP tend to have
more severe disease.
Detailed results from these trials will be submitted for
presentation at future medical meetings, and will form part of the
companies' regulatory submissions. The safety and efficacy of
Dupixent in CRSwNP is investigational and has not been evaluated by
any regulatory authority.
INDICATION
In the U.S., Dupixent is used to treat
adult patients 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.
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
- have asthma
- 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 have asthma and 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. Stop using Dupixent and go to the
nearest hospital emergency room if you get any of the following
symptoms: fever, general ill feeling, swollen lymph nodes, hives,
itching, 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.
The most common side effects include injection site
reactions, eye and eyelid inflammation, including redness, swelling
and itching, and cold sores in your mouth or on your
lips.
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 may report side effects
to FDA at 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.
Please click here for the full Prescribing
Information. The patient information is available
here.
Click here for information on the dupilumab development
program.
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 (EURONEXT: SAN) (NYSE: SNY) 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
Hala Mirza
Tel.: +1
914-847-3422
Hala.Mirza@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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