TARRYTOWN, N.Y. and
PARIS, Oct.
29, 2019 /PRNewswire/ --
First biologic approved in the European Union for adults with
severe chronic rhinosinusitis with nasal polyposis (CRSwNP)
Dupixent now approved in the EU for three type 2 inflammatory
diseases: severe CRSwNP, severe asthma and moderate-to-severe
atopic dermatitis
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi
today announced that the European Commission (EC) has approved a
new indication for Dupixent® (dupilumab) in chronic
rhinosinusitis with nasal polyposis (CRSwNP). Dupixent is indicated
as an add-on therapy with intranasal corticosteroids for the
treatment of adults with severe CRSwNP for whom therapy with
systemic corticosteroids and/or surgery do not provide adequate
disease control.
"People living with severe CRSwNP are often desperate to find
new treatment options, given that current standard treatments such
as intermittent courses of systemic corticosteroids or sinonasal
surgery are associated with disease recurrence," said George
D. Yancopoulos, M.D., Ph.D., President and Chief Scientific Officer
at Regeneron. "Dupixent significantly improved the signs and
symptoms of severe CRSwNP, and also eliminated the need for further
surgery or corticosteroid use in approximately three-quarters of
patients. Today's approval provides patients in Europe with the first biologic treatment to
address the type 2 inflammation that underlies most CRSwNP. This is
the third type 2 disease in which Dupixent has been approved, and
we continue to investigate Dupixent in a broad range of type 2
inflammatory diseases."
CRSwNP is a chronic disease of the upper airway that obstructs
the sinuses and nasal passages. It can lead to persistent breathing
difficulties, nasal congestion and discharge, reduced or loss of
sense of smell and taste, and facial pressure or pain.
"Many patients with CRSwNP have co-morbid asthma, and those
patients tend to have more severe disease that is often more
difficult to treat," said John Reed,
M.D., Ph.D., Global Head of Research and Development at
Sanofi. "These particular patients may have an increased risk
of asthma attacks, high symptom burden and a substantial adverse
impact on health-related quality of life. Nearly 60 percent of the
patients in the CRSwNP trials had asthma, and the data showed
Dupixent provided an additional benefit of improved lung function
in these patients."
The EC approval is based on two pivotal Phase 3 trials (the
24-week SINUS-24 and 52-week SINUS-52) that evaluated Dupixent 300
mg every two weeks plus standard-of-care intranasal corticosteroids
compared to placebo plus intranasal corticosteroids. In these
trials, Dupixent significantly improved key disease measures and
met all primary and secondary endpoints. At 24 weeks, patients
treated with Dupixent achieved statistically significant
improvements in all primary and secondary endpoints, including:
- Co-primary endpoints:
-
- 57% and 51% improvement in their nasal congestion/obstruction
severity compared to a 19% and 15% improvement with placebo in
SINUS-24 and SINUS-52, respectively (least squares [LS] mean change
from baseline of ‑1.34 and -1.25 for Dupixent compared to -0.45 and
-0.38 for placebo; difference between Dupixent and placebo: -0.89
and -0.87).
- 33% and 27% reduction in their nasal polyps score compared to a
7% and 4% increase with placebo in SINUS-24 and SINUS-52,
respectively (LS mean change from baseline of -1.89 and -1.71 for
Dupixent compared to 0.17 and 0.10 for placebo; difference between
Dupixent and placebo: -2.06 and -1.80).
- Secondary endpoints:
-
- 42% and 27% improvement in sinus opacification compared to 4%
and 0% with placebo in SINUS-24 and SINUS-52, respectively (LS mean
change from baseline of -8.18 and -5.21 for Dupixent compared to
-0.74 and -0.09 for placebo).
- 52% and 45% improvement in loss of smell compared to a 12% and
10% improvement for placebo in SINUS-24 and SINUS-52, respectively
(LS mean difference in Dupixent compared to placebo of -1.12 and
-0.98 in SINUS-24 and SINUS-52, respectively).
In a pre-specified pooled analysis of the two trials up to 52
weeks, Dupixent treatment resulted in a significant reduction of
systemic corticosteroid use and the need for sino‑nasal surgery
compared to placebo.
- The proportion of patients who required systemic
corticosteroids was reduced by 74% with Dupixent compared to
placebo.
- The proportion of patients who required surgery was reduced by
83% with Dupixent compared to placebo.
In a pre-specified analysis of the 59% of patients who also had
asthma, treatment with Dupixent:
- Improved lung function by 0.21 L compared with placebo as
measured by forced expiratory volume over one second
(FEV1).
- Improved asthma control as measured by the 6-item Asthma
Control Questionnaire (ACQ-6).
Treatment effects on nasal congestion and loss of smell were
observed with the first assessment at 4 weeks and showed continued
improvement for the duration of the trials.
In the CRSwNP clinical trials, the common (at least 1%) adverse
events in the Dupixent group were inflammation of the eye and
eyelids (conjunctivitis), high count of certain white blood cells
(eosinophilia), injection site reactions and injection site
swelling.
Dupixent is a fully-human monoclonal antibody that inhibits the
signaling of the interleukin-4 (IL-4) and interleukin-13 (IL-13)
proteins. Dupixent was invented using Regeneron's proprietary
VelocImmune® technology, which uses a unique
genetically-humanized mouse to produce optimized fully-human
antibodies. Data from Dupixent clinical trials have shown that
IL-4 and IL-13 are key drivers of the type 2 inflammation that
plays a major role in CRSwNP, asthma and atopic dermatitis.
About Dupixent
Dupixent comes in a 300 mg pre-filled syringe for patients with
CRSwNP. It is given as a subcutaneous injection every other week at
different injection sites. Dupixent is intended for use under the
guidance of a healthcare professional and can be given in a clinic
or at home by self-administration after training by a healthcare
professional.
In addition to severe CRSwNP, Dupixent is approved in the EU for
patients 12 years and older as an 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 (ICS) plus another medicinal product for maintenance
treatment. It is also approved in the EU for use in patients 12
years and older with moderate-to-severe atopic dermatitis who are
candidates for systemic therapy.
Outside of the EU, Dupixent is approved for use in specific
patients with moderate-to-severe atopic dermatitis and certain
patients with asthma in a number of other countries around the
world, including the U.S. and Japan. Dupixent is also approved in the U.S.
for use with other medicines to treat CRSwNP in adults whose
disease is not controlled.
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 pediatric asthma (6
to 11 years of age, Phase 3), pediatric atopic dermatitis (6 months
to 5 years of age, Phase 2/3 and 6 to 11 years of age, Phase 3),
eosinophilic esophagitis (Phase 2/3), chronic obstructive pulmonary
disease (Phase 3) and food and environmental allergies (Phase 2).
Dupilumab is also being studied in combination with REGN3500
(SAR440340), 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, are being jointly developed by Regeneron
and Sanofi under a global collaboration agreement.
U.S. INDICATIONS
DUPIXENT is a prescription medicine used:
- to treat people 12 years of age and older 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 12
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.
- with other medicines to treat chronic rhinosinusitis with nasal
polyposis in adults whose disease is not controlled. It is not
known if DUPIXENT is safe and effective in children with chronic
rhinosinusitis with nasal polyposis under 18 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
- 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. Tell your healthcare provider if you have
any new or worsening eye problems, including eye pain or changes in
vision.
- Inflammation of 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:
- Atopic dermatitis: injection site reactions, eye and
eyelid inflammation, including redness, swelling, and itching, and
cold sores in your mouth or on your lips.
- Asthma: injection site reactions, pain in the throat
(oropharyngeal pain), and high count of a certain white blood cell
(eosinophilia).
- Chronic rhinosinusitis with nasal polyposis: injection
site reactions, eye and eyelid inflammation, including redness,
swelling, and itching, high count of a certain white blood cell
(eosinophilia), trouble sleeping (insomnia), toothache, gastritis,
and joint pain (arthralgia).
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. DUPIXENT is an injection
given under the skin (subcutaneous injection). 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 children 12 years of age and older, it is
recommended that DUPIXENT be administered by or under supervision
of an adult.
Please see 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, infectious diseases,
pain and rare diseases.
Regeneron is accelerating and improving the traditional drug
development process through our
proprietary VelociSuite® technologies,
including VelocImmune® which uses a unique
genetically-humanized mouse to produce optimized fully-human
antibodies and bispecific antibodies, and through 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 pediatric asthma
and pediatric atopic dermatitis, eosinophilic esophagitis, chronic
obstructive pulmonary disease, food and environmental allergies,
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
dupilumab) in patients, including serious complications or side
effects in connection with the use of Regeneron's product
candidates in clinical trials; 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; 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; 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; the ability of Regeneron's collaborators,
suppliers, or other third parties (as applicable) to perform
manufacturing, filling, finishing, packaging, labeling,
distribution, and other steps related to Regeneron's products and
product candidates; 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; 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 and
other related proceedings relating to EYLEA®
(aflibercept) Injection, Dupixent, and Praluent®
(alirocumab) Injection, the ultimate outcome of any such
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 and its Form 10-Q
for the quarterly period ended June 30,
2019. 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,
2018. 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)
847-5018
Sharon.Chen@regeneron.com
|
Investor
Relations
Justin
Holko
Tel: +1 (914)
847-7786
Justin.Holko@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
|
View original
content:http://www.prnewswire.com/news-releases/dupixent-dupilumab-now-approved-in-european-union-for-severe-chronic-rhinosinusitis-with-nasal-polyposis-300947130.html
SOURCE Regeneron Pharmaceuticals, Inc.