Press Release: Dupixent approved in the EU as the first-ever
targeted therapy for patients with COPD
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 HudsonChief 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 and NOTUS 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 μL). 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 FEV1) 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 COPDCOPD 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
programBOREAS 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 [FEV1]) 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 programSanofi 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 DupixentDupixent 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
ProgramDupilumab 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 RegeneronRegeneron
(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 or follow Regeneron on LinkedIn,
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About SanofiWe 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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