Press Release: Dupixent recommended for EU approval by the CHMP to
treat patients with COPD
Dupixent recommended for EU approval by the CHMP to
treat patients with COPD
- Recommendation for adults with
uncontrolled COPD with raised blood eosinophils based on data from
two landmark Phase 3 trials demonstrating Dupixent significantly
reduced exacerbations and improved lung function
- If approved, Dupixent would be the
first-ever targeted therapy for COPD in the EU and the first new
treatment approach for this disease in more than a decade
Paris and Tarrytown, N.Y. May 31,
2024. The European Medicines Agency’s Committee for
Medicinal Products for Human Use (CHMP) adopted a positive opinion
recommending the approval of Dupixent (dupilumab) in the European
Union (EU) as an add-on maintenance treatment in adults with
uncontrolled chronic obstructive pulmonary disease (COPD)
characterized by raised blood eosinophils. The European Commission
is expected to announce a final decision on the Dupixent
application in the coming months.
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.
The positive CHMP opinion is supported by data
from the landmark BOREAS and NOTUS phase 3 studies that 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 (nearly all on triple therapy).
The primary endpoint was met in both studies, showing Dupixent
significantly reduced annualized moderate or severe acute COPD
exacerbations by up to 34% compared to placebo. Dupixent rapidly
and significantly improved lung function compared to placebo, with
improvements sustained at 52 weeks. Additionally, Dupixent improved
health-related quality of life at 52 weeks (statistically
significant in BOREAS and nominally significant in NOTUS) as
assessed by the St. George’s Respiratory Questionnaire (SGRQ).
Safety results in both studies were generally
consistent with the known safety profile of Dupixent in its
approved indications. Adverse events more commonly observed with
Dupixent (≥5%) compared to placebo in either study were back pain,
COVID-19, diarrhea, headache and nasopharyngitis.
Submissions are also under review with
regulatory authorities around the world, including in the U.S. and
China. Earlier this year, the U.S. Food and Drug Administration
(FDA) accepted for Priority Review the supplemental Biologics
License Application for Dupixent as an add-on maintenance treatment
in certain adult patients with uncontrolled COPD. The target action
date is September 27, 2024.
The use of Dupixent in COPD is investigational and
is not yet approved by global regulatory authorities.
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 (IL-4) and interleukin-13 (IL-13) 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, with two phase 3 studies currently enrolling, 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 (IL-4) and interleukin-13 (IL-13) 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 IL-4 and IL-13 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 (CRSwNP), eosinophilic esophagitis (EoE),
prurigo nodularis and chronic spontaneous urticaria (CSU) in
different age populations. More than 850,000 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, chronic obstructive pulmonary disease with evidence of type
2 inflammation 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,
Instagram, Facebook or X.
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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