Sanofi and
Regeneron Announce FDA Approval of Dupixent®
(dupilumab), the First Targeted Biologic Therapy for Adults with
Moderate-to-Severe Atopic Dermatitis
-
Dupixent will be available later this week to U.S. patients
suffering from this chronic and debilitating form of eczema
-
Paris, France and
Tarrytown, New York - March 28, 2017 - 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 MyWayTM, a
comprehensive and specialized program that provides support and
services to patients throughout every step of the treatment
process.
Dupixent
MyWayTM will
help eligible patients who are uninsured, lack coverage, or need
assistance with their out-of-pocket costs. Additionally, Dupixent MyWayTM 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
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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,"
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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
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enrollment, completion, and meeting of the relevant endpoints of
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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
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Contacts
Sanofi:
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Tel: 908-981-8745
ashleigh.koss@sanofi.com
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Mobile: 908-247-6006
carrie.brown@sanofi.com |
Investor
Relations
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69
ir@sanofi.com |
Contacts
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Mobile: 914-450-6677
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[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.
[iv] Friends of
Cancer Research. Breakthrough Therapies 2017.
https://www.focr.org/breakthrough-therapies. Accessed February 22,
2017.
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