TARRYTOWN, N.Y. and
PARIS, Sept. 15, 2018 /PRNewswire/ --
Results on skin clearing, itch and certain quality of life
measurements were presented today as a late-breaking oral
presentation at the 27th EADV Congress
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi
today presented detailed results from a pivotal Phase 3 trial
showing Dupixent® (dupilumab) monotherapy demonstrated a
significant improvement in signs and symptoms of atopic dermatitis
and certain quality of life measures in adolescent patients (12-17
years) with moderate-to-severe atopic dermatitis, whose disease was
inadequately controlled with topical therapies or for whom topical
treatment was medically inadvisable. These data were presented at
the 27th European Academy of Dermatology and Venereology
(EADV) Congress in Paris,
France.
There continues to be a significant unmet need for adolescents
with moderate-to-severe atopic dermatitis, whose disease cannot be
controlled with topical treatments. There are no systemic biologic
medications approved for this patient population. Dupixent is
currently approved for use in certain adult patients with
moderate-to-severe atopic dermatitis in countries including the
U.S., European Union, Canada and
Japan. The results from this trial
in adolescents form the basis of regulatory submissions for
patients ages 12 to 17.
"Limited treatment options leave adolescents with uncontrolled
moderate-to-severe atopic dermatitis to cope with intense,
unrelenting itch and skin lesions," said Amy S. Paller, M.D., Director of the
Northwestern University Skin Disease
Research Center and principal investigator of the trial. "The
results we are presenting today show the potential for Dupixent in
adolescents to not only help clear the skin and reduce itching, but
also improve certain aspects of quality of life in adolescents who
may be dealing with these unbearable symptoms."
The late-breaking presentation at EADV included the following
data:
The co-primary endpoint outside of the U.S. was 75% improvement
in Eczema Area and Severity Index (EASI-75) at 16 weeks. In the
U.S., the primary endpoint was the proportion of patients achieving
Investigator's Global Assessment (IGA) score of 0 (clear) or 1
(almost clear):
- 41.5% of patients who received Dupixent every two weeks and 38%
of patients who received Dupixent every four weeks achieved 75% or
greater skin improvement (EASI-75) compared to 8% with placebo (p
less than 0.001).
- 24% of patients who received weight-based dosing of Dupixent
every two weeks (200 mg or 300 mg) and 18% of patients who received
a fixed dose of Dupixent every four weeks (300 mg) achieved the
primary endpoint – clear or almost-clear skin (IGA; score of 0 or
1) – compared with 2% with placebo (p less than 0.001).
With regard to key secondary endpoints at 16 weeks:
- There was a 66% improvement in the Dupixent every two weeks
group and 65% improvement in the Dupixent every four weeks group in
average percent change from baseline in EASI score compared with a
24% improvement in the placebo group (p less than 0.001).
- There was a 48% improvement in the Dupixent every two weeks
group and 45.5% improvement in the Dupixent every four weeks group
in average percent change from baseline in the pruritus numerical
rating scale (NRS) compared with a 19% improvement in the placebo
group (p less than 0.001).
- 49% of patients who received Dupixent every two weeks and 39%
of patients who received Dupixent every four weeks achieved at
least a 3-point improvement on the peak pruritus numerical rating
scale (pp-NRS) compared to 9% with placebo (p less than 0.001). At
the beginning of the trial, patients reported a mean itch score of
7.6 on the 10-point pp-NRS scale.
Also at 16 weeks, additional secondary endpoints were:
- The majority of patients who received Dupixent (61% of patients
treated every two weeks and 55% of patients treated every four
weeks) achieved at least a 50% improvement in EASI (EASI-50)
compared to 13% with placebo (p less than 0.001).
- There was a 52% improvement in the Dupixent every two weeks
group and 47.5% improvement in the Dupixent every four weeks group
compared to an 18% improvement in the placebo group in mean percent
change from baseline in SCORing Atopic Dermatitis (SCORAD), a
combined measure of area and severity of atopic dermatitis on the
skin as well as patient-reported symptoms of itch and sleeplessness
(p less than 0.001).
- Patients who received Dupixent every two weeks or every four
weeks significantly improved quality of life measured by the
Children's Dermatology Life Quality Index (CDLQI) and
patient-reported symptoms measured by the Patient-Oriented Eczema
Measure (POEM) compared with placebo (p less than 0.001).
Additionally in the 16-week trial, 59% of patients on placebo
used rescue medications compared with 21% of patients receiving
Dupixent every two weeks and 32.5% of patients receiving Dupixent
every four weeks.
The overall rate of adverse events was 72% for Dupixent every
two weeks, 64% for Dupixent every four weeks and 69% for
placebo.
Adverse events that were observed more frequently with Dupixent
included injection site reactions (8.5% for Dupixent every two
weeks, 6% for Dupixent every four weeks compared with 3.5% for
placebo) and conjunctivitis (10% for Dupixent every two weeks, 11%
for Dupixent every four weeks compared with 5% for placebo). Skin
infections were numerically lower in the Dupixent groups (11% for
Dupixent every two weeks, 13% for Dupixent every four weeks
compared with 20% for placebo).
The safety and efficacy of Dupixent in the adolescent atopic
dermatitis population have not been fully evaluated by any
regulatory authority.
About the Dupixent Trial in Adolescent Patients
The
pivotal, Phase 3 trial evaluating the efficacy and safety of
Dupixent monotherapy in adolescent patients with moderate-to-severe
atopic dermatitis is the first Phase 3 trial of a biologic in this
patient population. The trial enrolled 251 patients who were 12
years to 17 years of age with moderate-to-severe atopic dermatitis
whose disease could not be adequately controlled with topical
medications or for whom topical treatment was medically
inadvisable.
Patients were randomized into one of three treatment groups for
the controlled period of 16 weeks: the first group was treated with
Dupixent subcutaneous injection 200 mg or 300 mg every two weeks,
based on weight (with an initial dose of 400 mg or 600 mg
respectively). The second group was treated with 300 mg Dupixent
every four weeks (with an initial dose of 600 mg), and the third
group was treated with placebo every two weeks. No topical
corticosteroids were permitted unless a patient had a severe flare
and required rescue medication.
The co-primary endpoints outside of the U.S. and a key secondary
endpoint in the U.S. was the proportion of patients who achieved
75% or greater skin improvement as measured by the EASI-75 at Week
16. EASI is a validated scale used to measure the extent and
severity of the disease. In the U.S., the primary endpoint of this
trial was the proportion of patients with an IGA score of 0 or 1 at
Week 16. The IGA is a 5-point scale ranging from 0 (clear) to 4
(severe) that measures overall severity of skin lesions.
In the trial, 92% of patients had at least one other atopic or
allergic condition, including 66% with allergic rhinitis, 61% with
food allergy, 54% with asthma, 29% with hives and 23% with allergic
conjunctivitis.
About Moderate-to-Severe Atopic
Dermatitis
Atopic dermatitis, a form of eczema, is a chronic
inflammatory disease with symptoms often appearing as a rash on the
skin. Moderate-to-severe atopic dermatitis is characterized by
rashes that can potentially cover much of the body, and can include
intense, persistent itching, skin lesions and skin dryness,
cracking, redness, crusting and oozing. Itch is one of the most
burdensome symptoms for patients and can be debilitating.
About Dupixent®
(dupilumab)
Dupixent works by inhibiting interleukin-4
and interleukin-13 (IL-4 and IL-13), which are important
contributors to Type 2 inflammation, a systemic, allergic response
known to play a role in moderate-to-severe atopic dermatitis.
In 2016, the U.S. Food and Drug Administration (FDA) granted
Breakthrough Therapy designation for Dupixent for the treatment of
moderate-to-severe (12 to 17 years of age) and severe (6 months to
11 years of age) atopic dermatitis not well controlled on topical
prescription medications.
Dupixent is currently approved in the U.S. as a treatment for
adults with moderate-to-severe atopic dermatitis whose disease is
not adequately controlled with topical prescription therapies or
when those therapies are not advisable. Dupixent is approved in the
European Union for use in adults with moderate-to-severe atopic
dermatitis (AD) who are candidates for systemic therapy. Dupixent
is also approved for certain patients with moderate-to-severe
atopic dermatitis in a number of other countries, including
Canada and Japan. More than 50,000 adult patients with
atopic dermatitis have been prescribed Dupixent to date.
About Type 2 Inflammation in Atopic Dermatitis
Through
scientific advances in immune based disease biology, we now
understand that a particular type of inflammation, called Type 2
inflammation, contributes to the cause of atopic dermatitis. The
immune system includes different immune cells and signaling
proteins, including interleukins. Interleukin-4 (IL-4) and
interleukin-13 (IL-13) are central drivers of Type 2 allergic
inflammation in atopic dermatitis, as well as a range of other
allergic or atopic diseases.
Dupilumab Development Program
Regeneron and Sanofi are
also studying dupilumab in a broad range of clinical development
programs for diseases driven by Type 2 inflammation, including
asthma (Phase 3), pediatric (6-11 years) atopic dermatitis (Phase
3), nasal polyps (Phase 3), eosinophilic esophagitis (Phase 3) and
grass allergy (Phase 2). Future trials are planned for chronic
obstructive pulmonary disease and food allergy (including peanut).
These potential uses are investigational and the safety and
efficacy have not been evaluated by any regulatory authority.
Dupilumab was discovered using Regeneron's proprietary
VelocImmune® technology that yields optimized
fully human antibodies, and is being jointly developed by Regeneron
and Sanofi under a global collaboration agreement.
IMPORTANT SAFETY INFORMATION AND INDICATION
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.
INDICATION
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.
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 six
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
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 nature, timing, and
possible success and therapeutic applications of Regeneron's
products, product candidates, and research and clinical programs
now underway or planned, including without limitation
Dupixent® (dupilumab) Injection; the likelihood, timing,
and scope of possible regulatory approval and commercial launch of
Regeneron's late-stage product candidates and new indications for
marketed products, such as dupilumab for the treatment of
moderate-to-severe atopic dermatitis in adolescents, pediatric
atopic dermatitis, asthma, nasal polyps, eosinophilic esophagitis,
grass allergy, chronic obstructive pulmonary disease, food allergy
(including peanut), and other potential indications; unforeseen
safety issues resulting from the administration of products and
product candidates (such as dupilumab) in patients, including
serious complications or side effects in connection with the use of
Regeneron's product candidates in clinical trials; the extent to
which the results from the research and development programs
conducted by Regeneron or its collaborators may be replicated in
other studies and lead to therapeutic applications; ongoing
regulatory obligations and oversight impacting Regeneron's marketed
products (such as Dupixent), research and clinical programs, and
business, including those relating to patient privacy;
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
product candidates, including without limitation dupilumab;
competing drugs and product candidates that may be superior to
Regeneron's products and product candidates; uncertainty of market
acceptance and commercial success of Regeneron's products and
product candidates and the impact of studies (whether conducted by
Regeneron or others and whether mandated or voluntary) on the
commercial success of Regeneron's products and product candidates;
the ability of Regeneron to manufacture and manage supply chains
for multiple products and product candidates; the ability of
Regeneron's collaborators, suppliers, or other third parties to
perform filling, finishing, packaging, labeling, distribution, and
other steps related to Regeneron's products and product candidates;
the availability and extent of reimbursement of the Company's
products (such as Dupixent) 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; 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 or collaboration 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 without
any further product success; and risks associated with intellectual
property of other parties and pending or future litigation relating
thereto, including without limitation the patent litigation
proceedings relating to EYLEA® (aflibercept) Injection,
Dupixent, and Praluent® (alirocumab) Injection, the
ultimate outcome of any such litigation proceedings, 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-Q for the quarterly period ended
June 30, 2018. 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 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 (http://newsroom.regeneron.com) and its
Twitter feed (http://twitter.com/regeneron).
Sanofi Forward-Looking Statements
This press release contains forward-looking statements as
defined in the Private Securities Litigation Reform Act of 1995, as
amended. Forward-looking statements are statements that are not
historical facts. These statements include projections and
estimates and their underlying assumptions, statements regarding
plans, objectives, intentions and expectations with respect to
future financial results, events, operations, services, product
development and potential, and statements regarding future
performance. Forward-looking statements are generally identified by
the words "expects", "anticipates", "believes", "intends",
"estimates", "plans" and similar expressions. Although Sanofi's
management believes that the expectations reflected in such
forward-looking statements are reasonable, investors are cautioned
that forward-looking information and statements are subject to
various risks and uncertainties, many of which are difficult to
predict and generally beyond the control of Sanofi, that could
cause actual results and developments to differ materially from
those expressed in, or implied or projected by, the forward-looking
information and statements. These risks and uncertainties include
among other things, the uncertainties inherent in research and
development, future clinical data and analysis, including post
marketing, decisions by regulatory authorities, such as the FDA or
the EMA, regarding whether and when to approve any drug, device or
biological application that may be filed for any such product
candidates as well as their decisions regarding labelling and other
matters that could affect the availability or commercial
potential of such product candidates, the absence of guarantee that
the product candidates if approved will be commercially successful,
the future approval and commercial success of therapeutic
alternatives, risks associated with intellectual property and any
related pending or future litigation and the ultimate outcome
of such litigation, trends in exchange rates and prevailing
interest rates, volatile economic conditions, the impact of cost
containment initiatives and subsequent changes thereto, as well as
those discussed or identified in the public filings with the SEC
and the AMF made by Sanofi, including those listed under "Risk
Factors" and "Cautionary Statement Regarding Forward-Looking
Statements" in Sanofi's annual report on Form 20-F for the year
ended December 31, 2017. Other than
as required by applicable law, Sanofi does not undertake any
obligation to update or revise any forward-looking information or
statements.
Regeneron
Contacts:
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Media
Relations
Sharon
Chen
Tel: +1 (914)
847-1546
Sharon.Chen@regeneron.com
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Investor
Relations
Manisha
Narasimhan, Ph.D.
Tel: 1 (914)
847-5126
Manisha.Narasimhan@regeneron.com
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Sanofi
Contacts:
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Media
Relations
Ashleigh
Koss
Tel: +1 (908)
981-8745
Ashleigh.Koss@sanofi.com
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Investor
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George
Grofik
Tel: +33 (0)1 53 77
45 45
ir@sanofi.com
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