Press Release: Dupixent approved in the US as the first-ever
biologic medicine for patients with COPD
Dupixent approved in the US as the first-ever
biologic medicine for patients with COPD
- Dupixent is indicated for the
approximately 300,000 adults in the US with inadequately controlled
COPD and an eosinophilic phenotype
- Following recent approvals in the
EU and China, the US approval is based on two landmark phase 3
studies that showed Dupixent achieved significant reduction in
exacerbations, and also showed improvements in lung function and
health-related quality of life compared to placebo
- Dupixent is the
leading biologic medicine for all of its FDA-approved indications
in new-to-brand prescriptions, and the most prescribed biologic by
pulmonologists in the US
Paris and Tarrytown, NY, September 27,
2024. The US Food and Drug Administration (FDA) has
approved Dupixent (dupilumab) as an add-on maintenance treatment of
adults with inadequately controlled chronic obstructive pulmonary
disease (COPD) and an eosinophilic phenotype. Dupixent is the first
biologic medicine approved in the US to treat these patients.
Jean Wright, M.D.
Chief Executive Officer at The COPD Foundation
“People living with inadequately controlled COPD have long
awaited new medicines to help manage the daily suffering they
experience from breathlessness, coughing, wheezing, exhaustion and
unpredictable hospitalization. These patients often
struggle with everyday activities many people take for granted such
as taking a walk or running errands outside the home. We
welcome the approval of this new therapeutic option to offer
patients a new way to help gain better control of their
disease.”
Paul Hudson
Chief Executive Officer at Sanofi
“Dupixent has already shown it can revolutionize the treatment
paradigm of many diseases driven in part by type 2 inflammation
with high unmet medical needs, with one million patients being
treated globally across all currently approved indications. With
today’s approval, Dupixent once again paves the way and becomes the
first and only approved add-on biologic medicine for inadequately
controlled COPD, giving patients living with this devastating
disease the chance to look forward to the potential of improved
breathing and a life with fewer exacerbations.”
The FDA approval is based on data from two landmark
pivotal phase 3 studies (BOREAS and NOTUS) that evaluated the
efficacy and safety of Dupixent compared to placebo in adults
currently on maximal standard-of-care inhaled therapy (nearly all
on triple therapy) with inadequately controlled COPD and blood
eosinophils ≥300 cells per μL. Patients who received Dupixent in
BOREAS (n=468) and NOTUS (n=470) experienced the following
outcomes, 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.
- 74mL and 68mL numerically greater
improvements in post-bronchodilator FEV1 from baseline
at week 12 compared to placebo, sustained at 52 weeks.
Statistically significant improvements of similar magnitude were
observed in pre-bronchodilator FEV1 from baseline at 12
and 52 weeks, a key secondary endpoint.
- 51% response in a health-related
quality of life measure in both trials compared to 43% and 47% with
placebo at 52 weeks, as assessed by a 4-point improvement on 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. In pooled BOREAS and NOTUS data, the most
common adverse events (>2%) more frequently observed in patients
on Dupixent compared to placebo were viral infection, headache,
nasopharyngitis, back pain, diarrhea, arthralgia, urinary tract
infection, local administration reaction, rhinitis, eosinophilia,
toothache, and gastritis. While less common, cholecystitis was
reported in 0.6% of patients on Dupixent compared to 0.1% of
patients on placebo.
George D. Yancopoulos, M.D.,
Ph.D.
Board Co-Chair, President and Chief Scientific Officer at
Regeneron
“This latest FDA approval for Dupixent represents new hope for
the hundreds of thousands of COPD patients in the US who can
sometimes struggle just to breathe during their everyday lives.
Dupixent has a proven track record as a first-in-class medicine,
providing benefit to the many patients suffering from type 2
inflammatory related diseases such as asthma and atopic dermatitis.
This latest approval represents an important next chapter for
Dupixent, giving those with COPD a novel option that has
demonstrated the unprecedented ability to help patients experience
fewer exacerbations, while also helping them breathe better and
improve quality of life in phase 3 studies.”
The FDA evaluated Dupixent under Priority Review,
which is reserved for medicines that represent potentially
significant improvements in efficacy or safety in treating serious
conditions. In July 2024, Sanofi and Regeneron announced that the
European Medicines Agency approved Dupixent as an add-on
maintenance treatment for adults with uncontrolled COPD
characterized by raised blood eosinophils. Submissions are
currently under review with other regulatory authorities around the
world, including in Japan.
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 medicine and/or antibiotics. Smoking and
exposure to noxious particles are key risk factors for COPD, but
even individuals who quit smoking can still have progressive lung
disease.
About half of COPD patients continue to experience
exacerbations despite being on triple inhaled therapy. In the US,
approximately 300,000 people live with inadequately controlled COPD
and an eosinophilic phenotype. Patients with an eosinophilic
phenotype contribute to an ~30% increase in exacerbations and an
increased risk of COPD-related re-hospitalizations within a
year.
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 an eosinophilic
phenotype, as defined by blood eosinophils ≥300 cells per µL. The
studies included adults with COPD across a broad range of clinical
presentations, including those with chronic bronchitis and
emphysema. 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 acute moderate or severe COPD exacerbations.
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.
The results of both BOREAS and NOTUS were
separately published in The New England Journal of
Medicine.
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 Dupixent, a
first-in-class biologic, and the investigation of 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 (IL33), an
initiator and amplifier of broad inflammation in COPD.
Itepekimab is currently under clinical
investigation for COPD 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 IL4 and 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 two of the
key and central drivers of type 2 inflammation that play a major
role in multiple related and often co-morbid diseases.
Sanofi and Regeneron are committed to helping
patients in the US 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.
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 polyps, eosinophilic esophagitis, prurigo nodularis,
chronic spontaneous urticaria, and COPD in different age
populations. More than 1,000,000 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 in part 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 or follow Regeneron on LinkedIn, Instagram,
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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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