Press Release: Update on FDA priority review of Dupixent for the
treatment of COPD patients with type 2 inflammation
Update on FDA priority review of Dupixent for
the treatment of COPD patients with type 2 inflammation
Paris and Tarrytown, NY May 31,
2024. The US Food and Drug Administration (FDA) has
extended by three months the target action date of its priority
review of the supplemental Biologics License Application (sBLA) for
Dupixent (dupilumab) as an add-on maintenance treatment in certain
adult patients with uncontrolled chronic obstructive pulmonary
disease (COPD). The revised target action date is September 27,
2024. The FDA did not raise any concerns regarding the
approvability of Dupixent for this indication.
The FDA had requested additional efficacy
analyses on the efficacy of Dupixent in the BOREAS and NOTUS
pivotal trials. Based on the submission of these analyses earlier
in May, the agency has now determined that this additional
information constituted a major amendment to the sBLA and extended
the target action date accordingly.
Sanofi and Regeneron are confident that the
additional analyses strongly support the approval of Dupixent in
COPD with evidence of type 2 inflammation, and are committed to
working with the FDA to bring Dupixent to patients living with
uncontrolled COPD as quickly as possible.
Additionally, submissions for Dupixent in COPD
are currently under review with regulatory authorities around the
world, including the European Union and China. Recently, the
European Medicines Agency’s (EMA) Committee for Medicinal Products
for Human Use (CHMP) adopted a positive opinion and recommended the
approval of Dupixent as an add-on maintenance treatment in adults
with uncontrolled COPD characterized by raised blood eosinophils.
The potential use of Dupixent in COPD is currently under clinical
development, and the safety and efficacy have not been fully
evaluated by any regulatory authority.
About BOREAS and NOTUS
Trials
The sBLA is supported by data from the landmark
BOREAS and NOTUS phase 3 studies evaluating the efficacy and safety
of Dupixent in adults who were current or former smokers with
uncontrolled COPD with type 2 inflammation (measured by blood
eosinophils ≥300 cells/microliter). 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.
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.
About COPD
COPD is a respiratory disease that damages the
lungs and causes progressive lung function decline. 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. In the US,
approximately 300,000 people live with uncontrolled COPD with
evidence of type 2 inflammation.
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 (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 Dupixent
Dupixent 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. These diseases include approved
indications for Dupixent, such as atopic dermatitis, asthma,
chronic rhinosinusitis with nasal polyposis (CRSwNP), eosinophilic
esophagitis (EoE), prurigo nodularis and chronic spontaneous
urticaria (CSU).
Dupixent has received regulatory approvals in
one or more countries around the world for use in certain patients
with atopic dermatitis, asthma, CRSwNP, EoE, prurigo nodularis and
CSU in different age populations. Dupixent is currently approved
for one or more of these indications in more than 60 countries,
including in Europe, the US and Japan. More than 850,000 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 spontaneous
urticaria, 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 some 100
countries, 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
Media RelationsSandrine
Guendoul | + 33 6 25 09 14 25 |
sandrine.guendoul@sanofi.comEvan Berland | +1 215
432 0234 | evan.berland@sanofi.comVictor Rouault |
+ 33 6 70 93 71 40 | victor.rouault@sanofi.comTimothy
Gilbert | + 1 516 521 2929 |
timothy.gilbert@sanofi.com
Investor RelationsThomas Kudsk
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thomas.larsen@sanofi.comAlizé Kaisserian | + 33 6
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arnaud.delepine@sanofi.comCorentine Driancourt | +
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Regeneron Media RelationsHannah
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hannah.kwagh@regeneron.com
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