Dupixent approved in the EU as the first-ever targeted therapy for patients with
COPD
* First-in-world approval of Dupixent for adults with uncontrolled COPD with
raised blood eosinophils based on two landmark phase 3 studies showing
Dupixent significantly reduced exacerbations, improved lung function and
also improved health-related quality of life
* Dupixent is the first new treatment approach for COPD in more than a decade
and a new option for approximately 220,000 adults in the EU
* Approval represents the sixth approved indication for Dupixent in the EU and
seventh approved indication globally
Paris and Tarrytown, NY, July 3, 2024. The European Medicines Agency (EMA) has
approved Dupixent (dupilumab) as an add-on maintenance treatment for adults with
uncontrolled chronic obstructive pulmonary disease (COPD) characterized by
raised blood eosinophils. Specifically, the approval covers patients already on
a combination of an inhaled corticosteroid (ICS), a long-acting beta2-agonist
(LABA) and a long-acting muscarinic antagonist (LAMA), or on a combination of a
LABA and a LAMA if ICS is not appropriate. The EMA is the first regulatory
authority in the world to approve Dupixent for COPD patients. Additional
submissions are under review with other regulatory authorities around the world,
including in the US, China, and Japan.
Tonya Winders
President & CEO of Global Allergy & Airways Patient Platform
"As a progressive and devastating disease, COPD leads to suffering from
breathlessness that limits a person's ability to conduct everyday activities
such as walking up the stairs or to the mailbox. Many patients feel marginalized
and isolated because of the physical and mental toll of the disease. After more
than a decade of limited treatment advancements for those living with
uncontrolled COPD, we are now in a new era of disease management for patients
and caregivers, and we welcome the addition of innovative, new treatments such
as Dupixent to help manage this progressive and irreversible disease."
Paul Hudson
Chief Executive Officer at Sanofi
"Patients with uncontrolled COPD have been waiting for a new treatment approach
for many years, so we are thrilled to bring to market the first biologic to
target an underlying cause of this devastating disease to reduce COPD
exacerbations and improve lung function. With today's approval of Dupixent, we
can change the treatment landscape for the more than 200,000 patients throughout
the EU living with uncontrolled COPD with raised blood eosinophils. We look
forward to working with other regulators around the world as quickly as possible
to bring this novel treatment approach to patients in more countries."
The approval is based on results from the landmark phase 3 BOREAS
(https://www.nejm.org/doi/full/10.1056/NEJMoa2303951) and NOTUS
(https://www.nejm.org/doi/full/10.1056/NEJMoa2401304) studies, which were
separately published in The New England Journal of Medicine and evaluated the
efficacy and safety of Dupixent in adults with uncontrolled COPD with evidence
of type 2 inflammation (i.e., blood eosinophils >=300 cells per ?L). All patients
were on background maximal standard-of-care inhaled therapy (with nearly all on
triple therapy). In terms of efficacy, Dupixent patients in BOREAS (n=468) and
NOTUS (n=470) experienced the following, respectively, compared to placebo
(BOREAS n=471; NOTUS n=465):
* 30% and 34% reduction in the annualized rate of moderate or severe COPD
exacerbations over 52 weeks, the primary endpoint.
* Improvements in lung function (pre-bronchodilator FEV(1)) from baseline by
160 mL and 139 mL at 12 weeks compared to 77 mL and 57 mL. These
improvements were observed as early as week 2 and 4 and were sustained at
52 weeks in both studies.
* Improvements in health-related quality of life (statistically significant in
BOREAS and nominally significant in NOTUS), as assessed by the St. George's
Respiratory Questionnaire.
Reductions in exacerbations and improvements in lung function for Dupixent
versus placebo were also observed in patients with higher baseline fractional
exhaled nitric oxide (>=20ppb) - an airway biomarker of inflammation - and across
all pre-defined subgroups including smoking status, baseline lung function, and
history of exacerbations.
Safety results in both studies were generally consistent with the known safety
profile of Dupixent in its approved indications. The most common side effects
across indications include injection site reactions, conjunctivitis,
conjunctivitis allergic, arthralgia, oral herpes, and eosinophilia. Adverse
events more commonly observed with Dupixent (>=5%) compared to placebo in either
COPD study were back pain, COVID-19, diarrhea, headache and nasopharyngitis.
Additional adverse reactions of injection site bruising, injection site
induration, injection site rash and injection site dermatitis were reported in
the COPD studies.
George D. Yancopoulos, M.D., Ph.D.
Board Co-Chair, President and Chief Scientific Officer at Regeneron
"The approval of Dupixent for COPD is a long-awaited turning point for those who
struggle to breathe even through the simplest of tasks, while also facing the
risk of hospitalization, irreversible health decline and feelings of
hopelessness. With this approval, we are proud that Dupixent has the potential
to redefine the treatment landscape in yet another disease, as a first-in-class
therapy demonstrating unprecedented improvements on exacerbations and lung
function, as well as improving health-related quality of life across two large
phase 3 trials."
About COPD
COPD is a respiratory disease that damages the lungs and causes progressive lung
function decline and is the fourth leading cause of death worldwide. Symptoms
include persistent cough, excessive mucus production and shortness of breath
that may impair the ability to perform routine daily activities, which may lead
to sleep disturbances, anxiety, and depression. COPD is also associated with a
significant health and economic burden due to recurrent acute exacerbations that
require systemic corticosteroid treatment and/or lead to hospitalization.
Smoking and exposure to noxious particles are key risk factors for COPD, but
even individuals who quit smoking can still develop or continue having the
disease. There have been no new treatment approaches approved for more than a
decade.
About the Dupixent COPD phase 3 study program
BOREAS and NOTUS were replicate, randomized, phase 3, double-blind, placebo-
controlled studies that evaluated the efficacy and safety of Dupixent in adults
who were current or former smokers with moderate-to-severe COPD with evidence of
type 2 inflammation, as measured by blood eosinophils >=300 cells per µL. The
studies enrolled 1,874 patients who were aged 40 to 80 years in BOREAS and 40 to
85 years in NOTUS.
During the 52-week treatment period, patients in BOREAS and NOTUS received
Dupixent or placebo every two weeks added to a maximal standard-of-care inhaled
triple therapy of ICS, LABA and LAMA. Double maintenance therapy, which included
LABA and LAMA, was allowed if ICS was not appropriate.
The primary endpoint for BOREAS and NOTUS evaluated the annualized rate of
moderate or severe COPD exacerbations. Moderate exacerbations were defined as
those requiring systemic steroids and/or antibiotics. Severe exacerbations were
defined as those requiring hospitalization; requiring more than a day of
observation in an emergency department or urgent care facility; or resulting in
death. Key secondary endpoints included change from baseline in lung function
(assessed by pre-bronchodilator forced expiratory volume (FEV(1))) at 12 and 52
weeks, change from baseline at 52 weeks in SGRQ total score compared to placebo,
and safety.
About Sanofi and Regeneron's COPD clinical research program
Sanofi and Regeneron are motivated to transform the treatment paradigm of COPD
by examining the role different types of inflammation play in the disease
progression through the investigation of two potentially first-in-class
biologics, Dupixent and itepekimab.
Dupixent inhibits the signaling of the interleukin-4 (IL4) and interleukin-13
(IL13) pathways and the program focuses on a specific population of people with
evidence of type 2 inflammation. Itepekimab is a fully human monoclonal antibody
that binds to and inhibits interleukin-33 (IL-33), an initiator and amplifier of
broad inflammation in COPD.
Itepekimab is currently under clinical investigation in two phase 3 studies, and
its safety and efficacy have not been evaluated by any regulatory authority.
About Dupixent
Dupixent is a fully human monoclonal antibody that inhibits the signaling of the
interleukin-4 (IL4) and interleukin-13 (IL13) pathways and is not an
immunosuppressant. The Dupixent development program has shown significant
clinical benefit and a decrease in type 2 inflammation in phase 3 studies,
establishing that IL4 and IL13 are key and central drivers of the type 2
inflammation that plays a major role in multiple related and often co-morbid
diseases.
Dupixent has received regulatory approvals in more than 60 countries in one or
more indications including certain patients with atopic dermatitis, asthma,
chronic rhinosinusitis with nasal polyposis, eosinophilic esophagitis, prurigo
nodularis, chronic spontaneous urticaria, and COPD in different age populations.
More than 900,000 patients are being treated with Dupixent globally.
Dupilumab Development Program
Dupilumab is being jointly developed by Sanofi and Regeneron under a global
collaboration agreement. To date, dupilumab has been studied across more than
60 clinical studies involving more than 10,000 patients with various chronic
diseases driven in part by type 2 inflammation.
In addition to the currently approved indications, Sanofi and Regeneron are
studying dupilumab in a broad range of diseases driven by type 2 inflammation or
other allergic processes in phase 3 studies, including chronic pruritus of
unknown origin and bullous pemphigoid. These potential uses of dupilumab are
currently under clinical investigation, and the safety and efficacy in these
conditions have not been fully evaluated by any regulatory authority.
About Regeneron
Regeneron (NASDAQ: REGN) is a leading biotechnology company that invents,
develops and commercializes life-transforming medicines for people with serious
diseases. Founded and led by physician-scientists, our unique ability to
repeatedly and consistently translate science into medicine has led to numerous
approved treatments and?product candidates in development, most 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, neurological diseases, hematologic
conditions, infectious diseases, and rare diseases.
Regeneron?pushes the boundaries of scientific discovery and?accelerates drug
development?using?our proprietary technologies, such as?VelociSuite(®), which
produces optimized fully human antibodies and new classes of bispecific
antibodies.?We are shaping the next frontier of medicine with data-powered
insights from the?Regeneron Genetics Center(®)?and pioneering genetic medicine
platforms, enabling us to identify innovative targets and complementary
approaches to potentially treat or cure diseases.
For more information, please visit www.Regeneron.com
(https://www.regeneron.com/) or follow Regeneron on LinkedIn
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About Sanofi
We are an innovative global healthcare company, driven by one purpose: we chase
the miracles of science to improve people's lives. Our team, across the world,
is dedicated to transforming the practice of medicine by working to turn the
impossible into the possible. We provide potentially life-changing treatment
options and life-saving vaccine protection to millions of people globally, while
putting sustainability and social responsibility at the center of our ambitions.
Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY
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