TARRYTOWN, N.Y. and
PARIS, March 8, 2019 /PRNewswire/ -- Regeneron
Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today
announced that the U.S. Food and Drug Administration (FDA) has
accepted for Priority Review the supplemental Biologics License
Application (sBLA) for Dupixent® (dupilumab) as an
add-on maintenance treatment for adults with inadequately
controlled severe chronic rhinosinusitis with nasal polyps
(CRSwNP). Patients with severe CRSwNP often experience recurrence
despite previous treatment with surgery and/or systemic
corticosteroids. The target action date for the FDA decision is
June 26, 2019.
Currently, there are no FDA-approved biologic medicines to treat
CRSwNP, a chronic disease of the upper airway predominantly driven
by type 2 inflammation and characterized by polyps that obstruct
the sinuses and nasal passages. Patients may experience severe
nasal obstruction with breathing difficulties, nasal discharge,
reduction or loss of sense of smell and taste, and facial pain or
pressure. Persistent symptoms of CRSwNP have a substantial adverse
impact on patients' health-related quality of life, which can be
measured by a composite that includes reduced productivity and
activities of daily living, inability to enjoy food, lack of sleep
and fatigue. People with co-morbid asthma and CRSwNP tend to have
more severe disease and are often more difficult to treat.
The sBLA is supported by data from two pivotal Phase 3 trials
evaluating the efficacy and safety of Dupixent when combined with
standard-of-care corticosteroid nasal spray in patients with
recurring severe CRSwNP despite previous treatment with surgery
and/or systemic corticosteroids. About 60% of patients in the
trials had co-morbid asthma. Data from these trials were presented
at the Annual Meeting of the American Academy of Allergy, Asthma
& Immunology (AAAAI) in February
2019. In addition to moderate-to-severe atopic dermatitis
and moderate-to-severe asthma, this is the third type 2
allergic inflammatory disease in which Dupixent has demonstrated
positive Phase 3 results.
Dupixent is a human monoclonal antibody specifically designed to
inhibit signaling of interleukin-4 and interleukin-13 (IL-4 and
IL-13). The findings from these trials, as well as from prior
trials in atopic dermatitis and asthma, demonstrate that both IL-4
and IL-13 are two key proteins that play a central role in type 2
inflammation, which seems to underlie CRSwNP as well as several
other allergic diseases.
In the U.S., Dupixent is approved for treatment of 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 is also
approved for use with other asthma medicines for the maintenance
treatment of moderate-to-severe asthma in people aged 12 years and
older whose asthma is not controlled with their current asthma
medicines. Dupixent is also approved for use in certain adult
patients with moderate-to-severe atopic dermatitis in countries of
the European Union (EU), and other countries including Canada and Japan.
On March 1, 2019, the European
Medicines Agency's (EMA) Committee for Medicinal Products for Human
Use (CHMP) adopted a positive opinion for the application for
Dupixent, recommending its approval in the EU as add-on maintenance
treatment for adult and adolescent (12 years and older) severe
asthma patients with type 2 inflammation characterized by increased
blood eosinophils and/or raised exhaled nitric oxide measured by
FeNO test and inadequately controlled by inhaled high dose
corticosteroids plus another asthma medicinal product. This
indication remains investigational in the EU, pending the adoption
of the CHMP opinion by the European Commission.
Other potential uses for Dupixent, including in CRSwNP, are
investigational and the safety and efficacy have not been evaluated
by the FDA, the EMA or any other regulatory authority. Dupilumab is
being developed jointly by Regeneron and Sanofi as part of a global
collaboration agreement.
Dupilumab Development Program
In addition to the
currently approved indications, Regeneron and Sanofi are also
studying dupilumab in a broad range of clinical development
programs for diseases driven by allergic and other type 2
inflammation, including chronic rhinosinusitis with nasal polyps
(Phase 3 completed), adolescent (12 to 17 years of age)
atopic dermatitis (Phase 3 completed), pediatric (6 to 11
years of age) atopic dermatitis (Phase 3), pediatric (6 months to 5
years of age) atopic dermatitis (Phase 2/3), pediatric (6 to 11
years of age) asthma (Phase 3), eosinophilic esophagitis (Phase
2/3), and food and environmental allergies (Phase 2). A future
trial is planned for chronic obstructive pulmonary disease.
Dupilumab is also being studied in combination with REGN3500, which
targets IL-33. These potential uses are investigational and the
safety and efficacy have not been evaluated by any regulatory
authority. Dupilumab and REGN3500 were invented using Regeneron's
proprietary VelocImmune® technology that yields
optimized fully human antibodies.
For more information on dupilumab clinical trials please visit
www.clinicaltrials.gov.
U.S. INDICATIONS
DUPIXENT is a prescription medicine used:
- to treat adults 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 with atopic
dermatitis under 18 years of age.
- with other asthma medicines for the maintenance treatment of
moderate-to-severe asthma in people aged 12 years and older
whose asthma is not controlled with their current asthma medicines.
DUPIXENT helps prevent severe asthma attacks (exacerbations) and
can improve your breathing. DUPIXENT may also help reduce the
amount of oral corticosteroids you need while preventing severe
asthma attacks and improving your breathing. DUPIXENT is not used
to treat sudden breathing problems. It is not known if
DUPIXENT is safe and effective in children with asthma under 12
years of age.
IMPORTANT SAFETY INFORMATION FOR U.S. PATIENTS
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 (if you also have atopic dermatitis)
- have a parasitic (helminth) infection
- are taking oral, topical, or inhaled corticosteroid medicines.
Do not stop taking your corticosteroid medicines unless
instructed by your healthcare provider. This may cause other
symptoms that were controlled by the corticosteroid medicine to
come back.
- 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 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 (hypersensitivity), including a severe
reaction known as anaphylaxis. Stop using DUPIXENT and tell
your healthcare provider or get emergency help right away if you
get any of the following symptoms: breathing problems, fever,
general ill feeling, swollen lymph nodes, swelling of the face,
mouth and tongue, hives, itching, fainting, dizziness, feeling
lightheaded (low blood pressure), joint pain, or skin rash.
- Eye problems. If you have atopic dermatitis, tell your
healthcare provider if you have any new or worsening eye problems,
including eye pain or changes in vision.
- Inflammation in your blood vessels: Rarely, this can
happen in people with asthma who receive DUPIXENT. This may
happen in people who also take a steroid medicine by mouth
that is being stopped or the dose is being lowered. It is not known
whether this is caused by DUPIXENT. Tell your healthcare
provider right away if you have: rash, shortness of breath,
persistent fever, chest pain, or a feeling of pins and needles or
numbness of your arms or legs.
The most common side effects
include injection site reactions, pain in the
throat (oropharyngeal pain) and cold sores in your mouth or on your
lips. Eye and eyelid inflammation, including redness,
swelling and itching have been seen in patients who have atopic
dermatitis.
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 are encouraged to
report negative side effects of prescription drugs to the FDA.
Visit www.fda.gov/medwatch, or call 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. In adolescents with asthma 12 years of age and
older, it is recommended that DUPIXENT be administered by or under
supervision of an adult.
Please see accompanying full Prescribing Information
including Patient Information.
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 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 chronic rhinosinusitis with nasal polyps, pediatric
atopic dermatitis, pediatric asthma, eosinophilic esophagitis,
grass allergy, food allergy (including peanut), chronic obstructive
pulmonary disease, and other potential indications (as well as in
combination with REGN3500); the impact of the recent
and any potential future U.S. government shutdowns on the
anticipated timing of the decision by the U.S. Food and Drug
Administration regarding the supplemental Biologics License
Application for Dupixent referenced in this press release; the
impact of the opinion adopted by the European Medicine Agency's
Committee for Medicinal Products for Human Use referenced in this
press release on the European Commission's decision regarding the
Marketing Authorization Application for Dupixent for use as an
add-on maintenance treatment in certain adults and adolescents (12
years of age and older) with inadequately controlled severe asthma
or oral corticosteroid-dependent asthma; 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; 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; 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; uncertainty of market acceptance
and commercial success of Regeneron's products and product
candidates (such as Dupixent) and the impact of studies (whether
conducted by Regeneron or others and whether mandated or voluntary)
on the commercial success of any such products and product
candidates; competing drugs and product candidates that may be
superior to Regeneron's products and product candidates; 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; 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
manufacturing, filling, finishing, packaging, labeling,
distribution, and other steps related to Regeneron's products and
product candidates; 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-K for the year ended December 31, 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 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,
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:
Media
Relations
Sharon
Chen
Tel: +1 (914)
847-1546
Sharon.Chen@regeneron.com
|
Investor
Relations
Mark
Hudson
Tel: +1 (914)
847-3482
Mark.Hudson@regeneron.com
|
|
|
Sanofi
Contacts:
Media
Relations
Ashleigh
Koss
Tel: +1 (908) 981
8745
Ashleigh.Koss@sanofi.com
|
Investor
Relations
George
Grofik
Tel: +33 (0)1 53 77
45 45
ir@sanofi.com
|
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SOURCE Regeneron Pharmaceuticals, Inc.