TARRYTOWN, N.Y. and
PARIS, June
26, 2019 /PRNewswire/ --
First biologic medicine for adults with inadequately
controlled chronic rhinosinusitis with nasal polyposis
(CRSwNP)
Dupixent significantly reduces nasal polyp size, improves
congestion and loss of smell, while reducing the need for surgery
and systemic corticosteroids
59% of clinical trial patients also had asthma, and
experienced improvements in their lung function
Dupixent now approved for three conditions with underlying
type 2 inflammation: moderate-to-severe atopic dermatitis,
moderate-to-severe asthma and CRSwNP
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi
today announced that the U.S. Food and Drug Administration (FDA)
has approved Dupixent® (dupilumab) for use with other
medicines to treat chronic rhinosinusitis with nasal polyposis
(CRSwNP) in adults whose disease is not controlled. CRSwNP can be a
debilitating condition, with many patients opting for systemic
steroids or nasal surgery, which often cannot control this disease.
Moreover, CRSwNP often occurs in combination with severe
asthma.
"Dupixent is the first FDA-approved medicine for adults with
chronic rhinosinusitis with nasal polyposis, and the only approved
therapy shown to shrink nasal polyp size and also improve the signs
and symptoms of the associated chronic rhinosinusitis. In fact,
approximately three-quarters of patients treated with Dupixent no
longer required either corticosteroids or surgery, the current
standards of care," said George D.
Yancopoulos, M.D., Ph.D., President and Chief Scientific
Officer at Regeneron. "Importantly, many patients with CRSwNP also
suffer from asthma, and Dupixent was shown to improve lung function
in these patients as well. This approval further reinforces that
IL-4 and IL-13 are key drivers of type 2 inflammation, and we
continue to study Dupixent in other type 2 inflammatory diseases,
including eosinophilic esophagitis, and food and environmental
allergies."
The FDA evaluated the CRSwNP Dupixent application under Priority
Review, which is reserved for medicines that represent potentially
significant improvements in efficacy or safety in treating serious
conditions.
Dupixent is a fully-human monoclonal antibody that inhibits the
signaling of interleukin-4 (IL-4) and interleukin-13 (IL-13), two
proteins that play a central role in type 2 inflammation. Data from
Dupixent clinical trials have shown that inhibiting IL-4 and IL-13
helps address the type 2 inflammation that plays a major role in
CRSwNP, asthma and atopic dermatitis.
"Chronic rhinosinusitis with nasal polyposis can be a
debilitating condition. Today's standard of care – which includes
intranasal and systemic corticosteroids and sinus surgery – often
leaves patients with CRSwNP with recurring symptoms," said
John Reed, M.D., Ph.D., Head of
Research and Development at Sanofi. "In two Phase 3 trials,
Dupixent helped patients significantly reduce their nasal
congestion, and many patients experienced significant improvement
in their sense of smell in as quickly as four weeks. Treatment with
Dupixent also reduced the need for systemic steroids and surgery,
and led to improvements in health-related quality of life.
Importantly, these patients with co-morbid asthma now have a
treatment that can help improve their breathing."
CRSwNP is a chronic disease of the upper airway that obstructs
the sinuses and nasal passages. It can lead to breathing
difficulties, nasal congestion and discharge, reduced or loss of
sense of smell and taste, and facial pressure. Many patients with
CRSwNP have other type 2 inflammatory diseases like asthma, and
these patients often have more severe asthma and are often more
difficult to treat. In the Dupixent CRSwNP trials, 59% of patients
also had asthma. These co-morbid diseases can lead to an increased
risk of asthma attacks, high symptom burden and a substantial
adverse impact on health-related quality of life.
The FDA approval is based on two pivotal trials (the 24-week
SINUS-24 and 52-week SINUS-52) that are part of the Phase 3 LIBERTY
clinical trial program. These trials evaluated Dupixent 300 mg
every two weeks with standard-of-care mometasone furoate nasal
spray (MFNS) compared to placebo injection plus MFNS. 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 the 59% of patients who also had asthma, the improvements in
lung function were similar to patients in the Dupixent asthma
program.
Treatment effects on nasal congestion and loss of smell were
observed with the first assessment as early as 4 weeks and showed
continued improvement for the duration of the trial. In the 52 week
SINUS-52 trial, patients continued to do well through the 52 week
treatment period.
In the CRSwNP clinical trials, adverse events that occurred in
at least 2% of Dupixent patients and greater than placebo were
injection site reactions (6% Dupixent, 4% placebo), conjunctivitis
(2% Dupixent, 1% placebo), arthralgia (3% Dupixent, 2% placebo) and
gastritis (2% Dupixent, 1% placebo).
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 CRSwNP, Dupixent is approved in the U.S. for use
with other asthma medicines for the maintenance treatment of
moderate-to-severe asthma in certain patients aged 12 years and
older whose asthma is not controlled with their current asthma
medicines; and to treat patients aged 12 years 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.
The wholesale acquisition cost of Dupixent remains unchanged
with the addition of this indication. Regeneron and Sanofi are
committed to helping patients in the U.S. who are prescribed
Dupixent gain access to the medicine and receive the support they
may need with the DUPIXENT MyWay® program. For
more information, please call 1-844-DUPIXENT (1-844-387-4936) or
visit www.DUPIXENT.com.
Outside of the U.S., Dupixent is approved in a number of
countries for use in certain adults with moderate-to-severe atopic
dermatitis. Dupixent is also approved in a number of other
countries, including those in the European Union (EU), Japan and Australia, to treat certain people aged 12
years and older with severe asthma. Dupixent is currently under
regulatory review for patients with CRSwNP in the EU, and for
adolescents with moderate-to-severe atopic dermatitis in several
countries, including Japan and in
the EU.
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 and atopic
dermatitis (6 to 11 years of age, Phase 3), pediatric atopic
dermatitis (6 months to 5 years of age, Phase 2/3), eosinophilic
esophagitis (Phase 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 were
invented using Regeneron's proprietary
VelocImmune® technology that yields optimized
fully human antibodies, and 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 Pharmaceuticals, Inc.
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 pediatric
asthma and atopic dermatitis, eosinophilic esophagitis, chronic
obstructive pulmonary disease, food and environmental allergies,
and other potential indications; 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 March 31,
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)
847-1546
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/fda-approves-dupixent-dupilumab-for-chronic-rhinosinusitis-with-nasal-polyposis-300875536.html
SOURCE Regeneron Pharmaceuticals, Inc.