Press Release: Dupixent® sBLA accepted for FDA Priority Review for
treatment of COPD with type 2 inflammation
Dupixent® sBLA accepted for FDA Priority Review for
treatment of COPD with type 2 inflammation
- Priority Review granted based on
positive results from two Phase 3 trials
- If approved, Dupixent would be the
only biologic therapy for COPD and the first new treatment approach
for the disease in more than a decade
- Regulatory submissions are also under
review in China and Europe
Paris and Tarrytown, N.Y. February 23,
2024. The U.S. Food and Drug Administration (FDA) has
accepted for Priority Review the supplemental Biologics License
Application (sBLA) for Dupixent® (dupilumab) in a sixth potential
indication as an add-on maintenance treatment in certain adult
patients with uncontrolled chronic obstructive pulmonary disease
(COPD). The target action date for the FDA decision is June 27,
2024. Regulatory submissions are also under review in China and the
European Union.
The sBLA, as well as other submissions around
the world, is supported by data from the Phase 3 COPD clinical
research program evaluating the efficacy and safety of Dupixent in
adults who were current or former smokers with uncontrolled COPD
with evidence of type 2 inflammation (screening 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 trials (BOREAS, NOTUS),
showing Dupixent significantly reduced moderate or severe acute
COPD exacerbations by 30% and 34% respectively, compared to
placebo. In both trials, Dupixent also rapidly and significantly
improved lung function compared to placebo, with improvements
sustained at 52 weeks.
Safety results in both trials 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 trial were back pain,
COVID-19, diarrhea, headache and nasopharyngitis.
Priority Review is granted to regulatory
applications seeking approval for therapies that have the potential
to provide significant improvements in the treatment, diagnosis or
prevention of serious conditions. The potential use of Dupixent in
COPD is currently under clinical development, and its safety and
efficacy for this indication have not been fully evaluated by any
regulatory authority.
About COPDCOPD is a respiratory
disease that damages the lungs and causes progressive lung function
decline. Symptoms include persistent cough, breathlessness and
excessive mucus production that may not only impair the ability to
perform routine daily activities, but can also lead to anxiety,
depression and sleep disturbances. 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 U.S., approximately 300,000 people live with
uncontrolled COPD with evidence of type 2 inflammation.
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 trials 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 trials, 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 U.S. and Japan. More than 800,000 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 trials
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 trials, 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 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 for over 35 years by
physician-scientists, our unique ability to repeatedly and
consistently translate science into medicine has led to numerous
FDA-approved treatments and product candidates in development,
almost all 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, hematologic conditions,
infectious diseases and rare diseases.
Regeneron is accelerating and improving the
traditional drug development process through our proprietary
VelociSuite® technologies, such as VelocImmune®, which uses unique
genetically humanized mice to produce optimized fully human
antibodies and bispecific antibodies, and through ambitious
research initiatives such as the Regeneron Genetics Center, which
is conducting one of the largest genetics sequencing efforts in the
world.
For more information about Regeneron, please
visit www.Regeneron.com or follow Regeneron
on LinkedIn.
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
Sanofi Media RelationsTimothy
Gilbert | + 1 516 521 2929 |
timothy.gilbert@sanofi.comVictor Rouault | + 33 6
70 93 71 40 | victor.rouault@sanofi.comEvan
Berland | + 1 215 432
0234| evan.berland@sanofi.comSally
Bain | + 1 617 834 6026
| sally.bain@sanofi.com
Sanofi Investor RelationsEva
Schaefer-Jansen | + 33 7 86 80 56 39 |
eva.schaefer-jansen@sanofi.comArnaud Delépine | +
33 06 73 69 36 93 | arnaud.delepine@sanofi.comCorentine
Driancourt | + 33 06 40 56 92 |
corentine.driancourt@sanofi.comFelix Lauscher | +
1 908 612 7239 | felix.lauscher@sanofi.comTarik
Elgoutni | + 1 617 710 3587 |
tarik.elgoutni@sanofi.comNathalie Pham | + 33 07
85 93 30 17 | nathalie.pham@sanofi.com
Regeneron Media RelationsHannah
Kwagh | +1 914-847-6314| hannah.kwagh@regeneron.com
Regeneron Investor RelationsVesna
Tosic | + 914 847 5443 | vesna.tosic@regeneron.com
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