TARRYTOWN, N.Y. and
PARIS, March 1, 2019 /PRNewswire/ -- Regeneron
Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today
announced that the European Medicines Agency's Committee for
Medicinal Products for Human Use (CHMP) has adopted a positive
opinion for Dupixent® (dupilumab) in asthma. The CHMP
recommended Dupixent be approved for use in adults and adolescents
12 years and older as add-on maintenance treatment for severe
asthma with type 2 inflammation characterized by raised blood
eosinophils and/or raised fractional exhaled nitric oxide (FeNO),
who are inadequately controlled with high dose inhaled
corticosteroid plus another medicinal product for maintenance
treatment.
The positive CHMP opinion is based on clinical data from 2,888
adults and adolescents who participated in three pivotal trials
from the global LIBERTY ASTHMA program, including the Phase 3 QUEST
and VENTURE trials. QUEST compared Dupixent vs. placebo in asthma
patients inadequately controlled on a medium or high dose inhaled
corticosteroid and a second controller medication. VENTURE
compared Dupixent vs. placebo in oral corticosteroid dependent
asthma patients. The European Commission is expected to make a
final decision on the application for Dupixent in the coming
months.
Dupixent is a human monoclonal antibody that inhibits the
signaling of interleukin-4 (IL-4) and interleukin-13 (IL-13), two
key proteins that play a central role in type 2 inflammation that
underlies specific types of asthma as well as several other
allergic diseases. This effect is associated with the reduction of
type 2 inflammatory biomarkers including FeNO, immunoglobulin E
(IgE) and eotaxin-3 (CCL26).
Patients with severe asthma often have uncontrolled, persistent
symptoms despite standard-of-care therapy that may make them
suitable for treatment with a biologic therapy. Symptoms of
uncontrolled disease include coughing, wheezing and difficulty
breathing, and these patients are at risk of severe asthma attacks
that may require emergency room visits or hospitalizations. Oral
corticosteroids can provide relief for severe, short-term symptoms;
however, current asthma guidelines suggest limiting their chronic
use to the most severe patients due to the potential for serious
side effects.
Dupixent is being developed jointly by Regeneron and Sanofi as
part of a global collaboration agreement. In October 2018, Dupixent was approved in the U.S.
as an add-on maintenance therapy in patients with
moderate-to-severe asthma aged 12 years and older with an
eosinophilic phenotype or with oral corticosteroid-dependent
asthma. Dupixent is not used to treat sudden breathing problems.
Dupixent is currently under regulatory review for specific types of
asthma in Japan.
Dupixent is currently approved in the European Union for use in
adults with moderate-to-severe atopic dermatitis who are candidates
for systemic therapy. Dupixent is also approved for use in specific
patients with moderate-to-severe atopic dermatitis in a number of
other countries around the world.
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 chronic rhinosinusitis with nasal polyps (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), adolescent (12 to 17 years of age) atopic
dermatitis (Phase 3 completed), 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
disease, 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 impact of the
opinion adopted by the European Medicine Agency's Committee for
Medicinal Products for Human Use discussed in this news release on
the European Commission's decision regarding the Marketing
Authorization Application for Dupixent for use as an add-on
maintenance treatment for adults and adolescents (12 years and
older) who have severe asthma with type 2 inflammation and who are
inadequately controlled with medium-to-high dose inhaled
corticosteroid plus another medicinal product for maintenance
treatment, and for the treatment of oral corticosteroid-dependent
asthma regardless of type 2 inflammatory biomarkers; 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, including possible
regulatory approval of Dupixent in the European Union discussed in
this news release and possible regulatory approval of Dupixent in
other jurisdictions and indications (such as for the treatment of
pediatric and adolescent atopic dermatitis, pediatric asthma,
chronic rhinosinusitis with nasal polyps, eosinophilic esophagitis,
grass allergy, food allergy (including peanut), chronic obstructive
pulmonary disease, and other potential indications (as well as in
combination with REGN3500)); unforeseen safety issues resulting
from the administration of products and product candidates (such as
Dupixent) 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 Dupixent; 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 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-Q for the quarterly period ended
September 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 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:
|
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Media
Relations
Sharon
Chen
Tel: +1 (914)
847-5018
Sharon.Chen@regeneron.com
|
Investor
Relations
Mark
Hudson
Tel: +1 (914)
847-3482
Mark.Hudson@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
|
Investor
Relations
George
Grofik
Tel: +33 (0)1 53 77
45 45
ir@sanofi.com
|
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SOURCE Regeneron Pharmaceuticals, Inc.