Sanofi and Regeneron Announce FDA Approval of Dupixent® (dupilumab), the First Targeted Biologic Therapy for Adults with Moderate-to-Severe Atopic Dermatitis
(Thomson Reuters ONE) -
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 MyWay(TM), a comprehensive and specialized program that
provides support and services to patients throughout every step of the treatment
process.
Dupixent MyWay(TM) will help eligible patients who are uninsured, lack coverage,
or need assistance with their out-of-pocket costs. Additionally, Dupixent
MyWay(TM) 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 (at)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
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include among other things, unexpected regulatory actions or delays, or
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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,
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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
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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," "seek," "estimate,"
variations of such words, and similar expressions are intended to identify such
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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 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
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assumptions underlying those projections or guidance; the potential for any
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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
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forward-looking statement, including without limitation any financial projection
or guidance, whether as a result of new information, future events, or
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Regeneron uses its media and investor relations website and social media outlets
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Contacts Sanofi:
Media Relations Investor Relations
Ashleigh Koss George Grofik
Tel: 908-981-8745 Tel.: +33 (0)1 53 77 94 69
ashleigh.koss(at)sanofi.com ir(at)sanofi.com
U.S. Communications
Carrie Brown
Tel: 908-981-6486
Mobile: 908-247-6006
carrie.brown(at)sanofi.com
Contacts Regeneron:
Media Relations Investor Relations
Ilana Tabak Manisha Narasimhan, Ph.D.
Tel: 1 (914) 847-3836 Tel: 1 (914) 847-5126
Mobile: 914-450-6677 Manisha.narasimhan(at)regeneron.com
ilana.tabak(at)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.
Press Release:
http://hugin.info/152918/R/2091156/790288.pdf
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Source: Sanofi via GlobeNewswire
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Datum: 28.03.2017 - 17:56 Uhr
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