Press
Release
Source: Sanofi (EURONEXT: SAN) (NYSE: SNY)
New England
Journal of Medicine publishes two positive Phase 3 trials showing
Dupixent® (dupilumab)
improved moderate-to-severe asthma
-
Results showed Dupixent demonstrated a
significant improvement in multiple asthma endpoints in two Phase 3
clinical trials in a broad population of patients with uncontrolled
asthma, irrespective of minimum baseline eosinophil levels or other
biomarkers of Type 2 inflammation
-
Greater benefit observed in patients with higher
levels of markers of Type 2 inflammation, as evidenced by
eosinophils or exhaled nitric oxide levels
-
In steroid-sparing VENTURE trial,
Dupixent-treated patients substantially reduced use of oral
corticosteroids, yet had fewer exacerbations and improved lung
function compared to placebo.
-
In both trials, Dupixent treated patients showed
significant lung function improvement two weeks after first dose
that was sustained over 52 weeks
Paris and
Tarrytown, NY - May 21, 2018 -The New England
Journal of Medicine (NEJM) today published detailed results
from two Phase 3 trials for the investigational use of
Dupixent® (dupilumab)
in moderate-to-severe asthma. The results showed that Dupixent
significantly reduced the risk of severe asthma attacks
(exacerbations), improved lung function and reduced dependence on
oral corticosteroids (OCS). The trials, known as QUEST and VENTURE,
are part of the pivotal clinical trial program that evaluated
Dupixent in uncontrolled asthma patients. These data were
simultaneously presented at the American Thoracic Society 2018
International Conference.
Dupixent demonstrated significant
improvements in the key primary and secondary endpoints across the
overall populations in both QUEST and VENTURE, with the largest
benefit experienced in patients with more severe Type 2
inflammatory asthma, as evidenced by elevated blood eosinophils or
exhaled nitric oxide levels. Type 2 asthma can also be
characterized by other parameters, including elevated
Immunoglobulin E (IgE). Dupixent blocks the IL-4/IL-13 pathway,
which is emerging as a central driver of Type 2 allergic
inflammation in asthma, as well as in a range of other allergic or
atopic diseases.
The investigational use of
Dupixent as an add-on maintenance treatment of adults and
adolescents with uncontrolled moderate-to-severe asthma is
currently under regulatory review in several countries, including
the U.S., Japan and in the European Union (EU), and the safety and
efficacy for this use have not been evaluated by any regulatory
authority. In the U.S., the target action date is October 20,
2018. Dupixent is currently approved in a number of countries for
the treatment of adults with uncontrolled moderate-to-severe atopic
dermatitis.
About LIBERTY
ASTHMA QUEST
The Phase 3 QUEST trial showed
that a broad population of adults and adolescents with
moderate-to-severe asthma (no minimum blood eosinophil level
requirement or other biomarker requirement at baseline) benefited
when Dupixent was added to their standard therapies. Dupixent
reduced severe asthma attacks and improved lung function compared
to placebo. Lung function improvements were observed from the first
measurement two weeks after receiving the first dose of Dupixent,
and improvements were sustained throughout the 52-week trial.
Patients also reported improved asthma control and quality of life,
as measured by the 5-item Asthma Control Questionnaire (ACQ-5) and
Asthma Quality of Life Questionnaire (AQLQ).
"About 20 percent
of people with asthma continue to have uncontrolled
moderate-to-severe symptoms despite available treatments," said
Mario Castro, M.D., Alan A. and Edith L. Wolff Professor of
Pulmonary and Critical Care Medicine at Washington University
School of Medicine in St. Louis. "The results published today in
the New England Journal of Medicine show evidence from a Phase 3
trial that a biologic may have the potential to help a broad
population of patients improve multiple key asthma treatment goals
when added to standard treatments. Dupixent was designed to inhibit
signaling from two important proteins (IL-4 and IL-13) involved in
Type 2 inflammation that contribute to uncontrolled symptoms in
many people with moderate-to-severe asthma."
The QUEST trial enrolled 1,902
patients worldwide including 1,795 adults and 107 adolescents. The
four study groups included patients treated with 200 mg every other
week (loading dose of 400 mg), 300 mg every other week (loading
dose of 600 mg) and two separate placebo groups. All patients
continued on a medium- or high-dose inhaled corticosteroid (ICS)
and up to two additional controller medicines throughout the
study.
The NEJM publication provides data
on key endpoints, including data in the table below.
QUEST Data Summary |
Placebo-adjusted reduction in annualized rate of severe
asthma exacerbations over 52 weeks |
|
200 mg Dupixent (n=631) vs. Placebo
(n=317) |
300 mg Dupixent (n=633) vs. Placebo
(n=321) |
Overall
population1 |
48
percent* |
46
percent* |
|
200 mg Dupixent (n=264) vs. Placebo
(n=148) |
300 mg Dupixent (n=277) vs. Placebo
(n=142) |
Patients
with 300 eosinophils/microliter or greater |
66
percent±* |
67
percent* |
Placebo-adjusted absolute (percent) change in lung function
(measured by FEV1) from
baseline to week 122 |
|
200 mg Dupixent (n=611) vs. Placebo
(n=307) |
300 mg Dupixent (n=610) vs. Placebo
(n=313) |
Overall
population1 |
140
mL*
(9 percent) |
130
mL*
(9 percent) |
|
200 mg Dupixent (n=256) vs. Placebo
(n=144) |
300 mg Dupixent (n=266) vs. Placebo
(n=139) |
Patients
with 300 eosinophils/microliter or greater |
210mL±
(13 percent) |
240mL*
(18 percent) |
1 Co-primary
endpoint, * p-value <0.001, ± p-value
nominal
2 Number of
patients with FEV1 measurement
at week 12
For the 52-week treatment period,
the overall rate of adverse events was similar across treatment
groups (81 percent in the combined Dupixent-treated group and 83
percent in the combined placebo-treated group). The rate of serious
adverse events was 8 percent in the combined Dupixent-treated group
and 8 percent in the combined placebo-treated group. The most
frequent adverse events that occurred more frequently with Dupixent
treatment vs. placebo were injection site reactions (17 percent vs.
8 percent, respectively), back pain (4 percent, both groups) and
eosinophilia (4 percent vs. 1 percent, respectively).
About LIBERTY
ASTHMA VENTURE
The Phase 3 VENTURE trial also did
not require minimum biomarker levels for enrollment. The
study showed that adults and adolescents with severe,
steroid-dependent asthma who were treated with Dupixent, when added
to standard therapies, could reduce their use of OCS medications
while improving asthma control compared to placebo at 24 weeks.
With Dupixent, OCS use decreased by 70 percent in the overall
population (vs. 42 percent for placebo), and 80 percent for
patients with baseline eosinophil levels 300 cells/microliter or
greater (vs. 43 percent for placebo). Despite reductions in OCS,
patients treated with Dupixent reduced the risk of severe asthma
attacks and improved their lung function.
"Up to 45 percent
of people with severe asthma rely on systemic corticosteroids to
control their symptoms but potential long-term side-effects should
be taken into account according to global asthma treatment
guidelines," said Klaus Rabe, MD, Director of
the Department of Pneumology at LungenClinic Grosshansdorf and
Professor of Medicine at Christian Albrechts University, Kiel,
Germany. "In the Phase 3 VENTURE trial, a majority of patients
treated with Dupixent and standard therapies significantly reduced
their use of oral steroids, and nearly half of patients completely
stopped using oral steroids, while improving their asthma."
The 24-week VENTURE study enrolled
210 patients (103 in the Dupixent group and 107 in the placebo
group) with severe asthma who regularly used maintenance OCS in the
six months prior to enrollment in the study. The two study groups
were 300 mg Dupixent every other week (loading dose of 600 mg) and
placebo. All patients continued on a high-dose ICS and up to two
additional controller medicines throughout the study. The
prescribed OCS in the study was prednisone or prednisolone.
The NEJM publication provides data
on key endpoints, including data in the tables below.
VENTURE Data Summary |
Reduction in OCS dose at 24 weeks |
|
300 mg Dupixent (n=103) |
Placebo (n=107) |
Overall
population1 |
70
percent* |
42
percent |
|
300 mg Dupixent (n=48) |
Placebo (n=41) |
Patients with 300 eosinophils/microliter or greater |
80
percent* |
43
percent |
Proportion of patients with 50 percent or greater reduction
in OCS |
Overall
population |
80
percent* |
50
percent |
Proportion of patients who reduced their OCS dose to less
than 5 mg per day |
Overall
population |
69
percent* |
33
percent |
1 Primary
endpoint, * p-value vs. placebo <0.001
|
VENTURE Data Summary, Continued |
|
Difference between 300 mg DUPIXENT (n=103) vs. Placebo
(n=107)
(Overall population) |
Difference between 300 mg DUPIXENT (n=48)
vs. Placebo (n=41)
(Patients with 300 eosinophils/ microliter or greater) |
Change in annualized rate of severe asthma exacerbations
over 24 weeks |
59 percent
reduction* |
71 percent reduction± |
Absolute (percent) change in FEV1 from baseline
to 24 weeks |
220 mL (15
percent***) improvement*
|
320 mL (25 percent***) improvement± |
* Nominal p-value vs. placebo < 0.001
±Nominal
p-value vs. placebo < 0.005
*** Data not included in NEJM publication
For the 24-week treatment period,
the overall rate of adverse events was similar across treatment
groups (62 percent in the Dupixent-treated group and 64.5 percent
in the placebo-treated group). The rate of serious adverse events
was 9 percent in the Dupixent-treated group and 6 percent in the
placebo-treated group. The most frequent adverse events that
occurred more frequently with Dupixent treatment vs. placebo were
injection site reaction (9 percent vs. 4 percent, respectively),
bronchitis (7 percent vs. 6 percent, respectively), sinusitis (7
percent vs. 4 percent, respectively) and eosinophilia (14 percent
vs. 1 percent, respectively).
Dupilumab
Development Program
Sanofi and Regeneron are also
studying dupilumab in a broad range of clinical development
programs for diseases driven by Type 2 inflammation, including
pediatric atopic dermatitis (Phase 3), nasal polyps (Phase 3) and
eosinophilic esophagitis (Phase 2). Future trials are planned for
chronic obstructive pulmonary disease, grass allergy and food
allergy (including peanut). These potential uses are
investigational and the safety and efficacy have not been evaluated
by any regulatory authority. Dupilumab is being jointly developed
by Sanofi and Regeneron under a global collaboration agreement.
For more information on dupilumab
clinical trials please visit www.clinicaltrials.gov.
About Dupixent® (dupilumab)
Dupixent is currently approved in
the U.S. for the treatment of adults with moderate-to-severe atopic
dermatitis whose disease is not adequately controlled with topical
prescription therapies, or when those therapies are not advisable.
Dupixent is also approved for use in certain patients with
moderate-to-severe atopic dermatitis in the EU and a number of
other countries, including Canada, and Japan.
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. Dupixent is
administered by subcutaneous injection at different injection sites
every two weeks after an initial loading dose. Dupixent is intended
for use under the guidance of a healthcare provider. A patient may
self-inject Dupixent after training in subcutaneous injection
technique using the pre-filled syringe.
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
|
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 six
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, heart disease, allergic and inflammatory diseases, pain,
cancer, 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.
Sanofi Media Relations Contact
Ashleigh Koss
Tel.: +1 908-981-8745
mr@sanofi.com
Regeneron Media Relations
Contact
Sharon Chen
Tel.: +1 914-847-1546
sharon.chen@regeneron.com
|
Investor Relations Contact George
Grofik
Tel.: +33 (0)1 53 77 45 45
ir@sanofi.com
Regeneron Investor Relations Contact
Manisha Narasimhan, Ph.D.
Tel: +1 914-847-5126
Manisha.narasimhan@regeneron.com |
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 Forward-Looking Statements and Use of Digital
Media
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 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 inadequately
controlled moderate-to-severe asthma (including possible regulatory
approval of dupilumab in the United States, Japan and the European
Union referenced in this news release), pediatric atopic
dermatitis, nasal polyps, eosinophilic esophagitis, chronic
obstructive pulmonary disease, food allergy, and other potential
indications; the extent to which the results from the research and
development programs conducted by Regeneron or its collaborators
may be replicated in later studies and lead to therapeutic
applications; unforeseen safety issues and possible liability
resulting from the administration of products and product
candidates in patients, including without limitation dupilumab;
serious complications or side effects in connection with the use of
Regeneron's products and product candidates (such as dupilumab) 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 candidates;
the ability of Regeneron to manufacture and manage supply chains
for multiple products and product candidates; unanticipated
expenses; the costs of developing, producing, and selling products;
the ability of Regeneron to meet any of its sales or other
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 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 United States
Securities and Exchange Commission, including its Form 10-K for the
year ended December 31, 2017 and its Form 10-Q for the quarterly
period ended March 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).
|
anofi
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
Press Release
This
announcement is distributed by Nasdaq Corporate Solutions on behalf
of Nasdaq Corporate Solutions clients.
The issuer of this announcement warrants that they are solely
responsible for the content, accuracy and originality of the
information contained therein.
Source: Sanofi via Globenewswire
Grafico Azioni Sanofi (EU:SAN)
Storico
Da Mar 2024 a Apr 2024
Grafico Azioni Sanofi (EU:SAN)
Storico
Da Apr 2023 a Apr 2024