BRIDGEWATER, N.J. and
TARRYTOWN, N.Y., March 28, 2017 /PRNewswire/ -- Sanofi and
Regeneron Pharmaceuticals, Inc. announced today that the U.S. Food
and Drug Administration (FDA) approved Dupixent®
(dupilumab) Injection, the first and only biologic medicine
approved for the treatment of adults with moderate-to-severe atopic
dermatitis (AD) whose disease is not adequately controlled with
topical prescription therapies, or when those therapies are not
advisable.
"People with moderate-to-severe atopic dermatitis cope with
intense, sometimes unbearable symptoms that can impact them for
most of their lives," said Julie
Block, President and Chief Executive Officer, National
Eczema Association. "To date, there have been few options
available to treat people with moderate-to-severe atopic dermatitis
who have uncontrolled disease. That's why today's approval of
Dupixent is so important for our community. Now we have a treatment
that is expected to help address patients suffering from this
devastating disease."
Dupixent is a human monoclonal antibody that is designed to
specifically inhibit overactive signaling of two key proteins, IL-4
and IL-13, which are believed to be major drivers of the persistent
underlying inflammation in AD. Dupixent comes in a pre-filled
syringe and can be self-administered as a subcutaneous injection
every other week after an initial loading dose. Dupixent can be
used with or without topical corticosteroids. It should not be used
in patients who are allergic to dupilumab or any of the ingredients
in Dupixent.
AD, the most common form of eczema, is a chronic inflammatory
disease with symptoms often appearing as a rash on the skin.
Moderate-to-severe AD is characterized by rashes often covering
much of the body, and can include intense, persistent itching and
skin dryness, cracking, redness, crusting, and oozing.i
Itch is one of the most burdensome symptoms for patients and can be
debilitating.ii Of the adults with
uncontrolled moderate-to-severe AD in the
United States, it is estimated that 300,000 are most in need
of new treatment options.iii
"Dupixent is the result of years of tireless research by our
scientists into the underlying causes of allergic and atopic
diseases. In atopic dermatitis, Dupixent was shown to help
clear the skin and manage the intense itch caused by the
disease," said George D.
Yancopoulos, M.D., Ph.D., Founding Scientist, President, and
Chief Scientific Officer, Regeneron. "Today's approval
would not be possible without the dedication of the clinical
investigators and the participation of the patients who took part
in the global LIBERTY AD clinical program."
Dupixent was evaluated by the FDA with Priority Review, which is
reserved for medicines that represent potentially significant
improvements in safety or efficacy in treating serious conditions.
This followed the FDA's 2014 Breakthrough Therapy designation for
Dupixent for inadequately controlled moderate-to-severe AD.
Breakthrough Therapy designation was created by the FDA to expedite
the development and review of drugs developed for serious or
life-threatening conditions/ Dupixent represents the first time
this designation was granted for a dermatological disease, other
than in dermatologic cancers.iv
"We strive to transform scientific innovation into
therapeutic solutions that make a meaningful difference
to people's lives," said Olivier
Brandicourt, M.D., Chief Executive Officer, Sanofi. "The
approval of Dupixent offers new hope for adults with
moderate-to-severe AD in the United
States, and we look forward to working with regulatory
authorities around the world to bring this important new medicine
to patients globally."
Sanofi Genzyme, the specialty care global business unit of
Sanofi, and Regeneron will market Dupixent in the United States. Dupixent is expected to be
available to patients and providers in the U.S. later this
week.
Sanofi and Regeneron recognize that Dupixent can only help those
uncontrolled moderate-to-severe AD patients that were prescribed
the medicine if they can both access the medicine and use it
properly. Therefore, the companies have launched Dupixent
MyWay™, a comprehensive and specialized
program that provides support and services to patients throughout
every step of the treatment process.
Dupixent MyWay™ will help eligible patients
who are uninsured, lack coverage, or need assistance with their
out-of-pocket costs. Additionally, Dupixent
MyWay™ offers personalized support from
registered nurses and other specialists who are available 24/7 to
speak with patients and help them navigate the complex insurance
process. For more information, please call 1-844-Dupixent
(1-844-387-4936) or visit www.Dupixent.com.
The Wholesale Acquisition Cost (WAC) of Dupixent in the United States is $37,000 annually. Actual costs to patients,
payers and health systems are anticipated to be lower as WAC
pricing does not reflect discounts, rebates or patient assistance
programs.
LIBERTY AD Clinical Program and Results
The approval
of Dupixent was based on data from the global LIBERTY AD clinical
program, which included three randomized Phase 3 pivotal trials
known as SOLO 1, SOLO 2 and CHRONOS (enrolled 2,119 total adult
patients). The studies examined the use of Dupixent either
alone (SOLO 1 or SOLO 2, 1,379 adult patients enrolled) or with
topical corticosteroids (CHRONOS, 740 adult patients enrolled) in
patients with inadequately controlled moderate-to-severe AD. In all
these studies, Dupixent alone or with topical corticosteroids met
the primary and key secondary endpoints, specifically:
- In the SOLO 1 and SOLO 2 studies, treatment with Dupixent as
monotherapy significantly improved measures of skin clearing and
overall extent and severity of disease:
- At 16 weeks, for SOLO 1 and SOLO 2, respectively, 38 and 36
percent of patients who received Dupixent 300 mg every two weeks
achieved clear or almost clear skin as measured by the 5-point
Investigator's Global Assessment (IGA) scale (primary endpoint),
compared to 10 and 9 percent with placebo.
- At 16 weeks, for SOLO 1 and SOLO 2, respectively, 51 and 44
percent of patients who received Dupixent 300 mg every two weeks
achieved a 75 percent or greater reduction in their Eczema Area and
Severity Index score (EASI-75) from baseline, a key secondary
endpoint, compared to 15 and 12 percent with placebo.
- At 16 weeks, for SOLO 1 and SOLO 2, respectively, 41 and 36
percent of patients who received Dupixent 300 mg every two weeks
achieved a greater than or equal to 4 point improvement in the
daily intensity of patient-reported itch, as measured by the
Pruritus Numerical Rating Scale (NRS), compared to 12 and 10
percent with placebo.
- In the CHRONOS study, treatment with Dupixent with topical
corticosteroids (TCS) significantly improved measures of overall
disease severity at 16 and 52 weeks, when compared to placebo with
TCS:
- At 16 weeks, 39 percent of patients who received Dupixent 300
mg every two weeks with TCS achieved clear or almost clear skin
(IGA 0 or 1), the primary endpoint, compared to 12 percent of
patients receiving placebo with TCS.
- At 16 weeks, 69 percent of patients who received Dupixent 300
mg every two weeks with TCS achieved EASI-75 (key secondary
endpoint), a 75 percent reduction on an index measuring eczema
severity, compared to 23 percent of patients receiving placebo with
TCS.
- At 16 weeks, 59 percent of patients who received Dupixent 300
mg every two weeks with TCS achieved a greater than or equal to 4
point improvement in the daily intensity of patient-reported itch,
as measured by the NRS, compared to 20 percent of patients
receiving placebo with TCS.
- The study also met additional key secondary endpoints at 52
weeks, showing that 36 percent of patients who received Dupixent
300 mg every two weeks with TCS achieved clear or almost clear skin
(IGA 0 or 1), compared to 13 percent of patients receiving placebo
with TCS.
The most common adverse events that were noted to be greater
than or equal to one percent with Dupixent treatment included
injection site reactions, eye and eye lid inflammation including
redness, swelling, and itching, and cold sores in the mouth or on
the lips.
In December 2016, the European
Medicines Agency accepted for review Sanofi's and Regeneron's
marketing authorization application (MAA) for Dupixent for adults
with uncontrolled moderate-to-severe AD.
Dupilumab Program Overview
Dupilumab is currently
being evaluated in a comprehensive development program for AD that
includes studies in children with severe AD (6 months to 11 years
of age) and adolescents with moderate-to-severe AD (12 to 17 years
of age). In October 2016, the FDA
granted dupilumab Breakthrough Therapy designation for both
populations. These potential uses are investigational and the
safety and efficacy have not been evaluated nor confirmed by any
regulatory authority.
Dupilumab is also being studied in other inflammatory diseases
that are believed to be driven by IL-4 and IL-13 cytokines,
including persistent uncontrolled asthma (Phase 3, results expected
later this year), nasal polyposis (Phase 3) and eosinophilic
esophagitis (Phase 2). These potential uses are investigational and
the safety and efficacy have not been evaluated by any regulatory
authority. For more information on dupilumab clinical trials please
visit www.clinicaltrials.gov.
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 if
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, 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 Sanofi
Sanofi, a global healthcare leader,
discovers, develops and distributes therapeutic solutions focused
on patients' needs. Sanofi is organized into five global business
units: Diabetes and Cardiovascular, General Medicines and Emerging
Markets, Sanofi Genzyme, Sanofi Pasteur and Consumer Healthcare.
Sanofi is listed in Paris
(EURONEXT: SAN) and in New York
(NYSE: SNY).
Sanofi Genzyme focuses on developing specialty treatments for
debilitating diseases that are often difficult to diagnose and
treat, providing hope to patients and their families.
About Regeneron Pharmaceuticals, Inc.
Regeneron
(NASDAQ: REGN) is a leading science-based biopharmaceutical company
that discovers, invents, develops, manufactures and commercializes
medicines for the treatment of serious medical conditions.
Regeneron commercializes medicines for eye diseases, high
LDL-cholesterol, atopic dermatitis and a rare inflammatory
condition and has product candidates in development in other areas
of high unmet medical need, including rheumatoid arthritis, asthma,
pain, cancer and infectious diseases. For additional information
about the company, please visit www.regeneron.com or follow
@Regeneron on Twitter.
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 regarding
the marketing and other potential of the product, or regarding
potential future revenues from the product. 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, unexpected regulatory actions or delays, or government
regulation generally, that could affect the availability or
commercial potential of the product, the absence of guarantee that
the product will be commercially successful, the uncertainties
inherent in research and development, including future clinical
data and analysis of existing clinical data relating to the
product, including post marketing, unexpected safety, quality or
manufacturing issues, competition in general, risks associated with
intellectual property and any related future litigation and the
ultimate outcome of such litigation, and volatile economic
conditions, as well as those risks 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,
2016. Other than as required by applicable law, Sanofi does
not undertake any obligation to update or revise any
forward-looking information or statements.
Regeneron Forward-Looking Statements
This
news 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 Dupixent for the treatment of uncontrolled
moderate-to-severe atopic dermatitis in jurisdictions outside
the United States and other
potential indications; unforeseen safety issues and possible
liability resulting from the administration of products and product
candidates in patients, including without limitation Dupixent;
serious complications or side effects in connection with the use of
Regeneron's products and product candidates (such as Dupixent) in
clinical trials; coverage and reimbursement determinations by
third-party payers, including Medicare, Medicaid, and pharmacy
benefit management companies; ongoing regulatory obligations and
oversight impacting Regeneron's marketed products, research and
clinical programs, and business, including those relating to the
enrollment, completion, and meeting of the relevant endpoints of
post-approval studies; 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, such as Dupixent;
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; unanticipated
expenses; the costs of developing, producing, and selling products;
the ability of Regeneron to meet any of its sales or other
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 relating to Praluent®
(alirocumab) Injection, the permanent injunction granted by the
United States District Court for the District of Delaware that, if upheld on appeal, would
prohibit Regeneron and Sanofi from marketing, selling, or
manufacturing Praluent in the United
States, the outcome of any appeals regarding such
injunction, the ultimate outcome of such litigation, 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 United States Securities and Exchange
Commission, including its Form 10-K for the year ended December 31, 2016. 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).
Contacts
Sanofi:
|
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Media
Relations
Ashleigh
Koss
Tel:
908-981-8745
ashleigh.koss@sanofi.com
U.S.
Communications
Carrie
Brown
Tel:
908-981-6486
Mobile:
908-247-6006
carrie.brown@sanofi.com
|
Investor
Relations
George
Grofik
Tel.: +33 (0)1 53 77
94 69
ir@sanofi.com
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Contacts
Regeneron:
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Media
Relations
Ilana
Tabak
Tel: 1 (914)
847-3836
Mobile:
914-450-6677
ilana.tabak@regeneron.com
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Investor
Relations
Manisha
Narasimhan, Ph.D.
Tel: 1 (914)
847-5126
Manisha.narasimhan@regeneron.com
|
_____________________________
|
i Mount
Sinai. Patient Care Atopic Dermatitis 2016.
http://www.mountsinai.org/patient-care/health-library/diseases-and-conditions/atopic-dermatitis#risk.
Accessed October 31, 2016.
|
ii
Zuberbier T, Orlow SJ, Paller AS, et al. Patient perspectives on
the management of atopic dermatitis. J Allergy Clin Immunol. 2006;
118:226-232.
|
iii Data
on file.
|
iv Friends
of Cancer Research. Breakthrough Therapies 2017.
https://www.focr.org/breakthrough-therapies. Accessed February 22,
2017.
|
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