Dupixent approved in the US as the only targeted
medicine to treat patients with bullous pemphigoid
- Approval based on pivotal results
showing improvements in sustained disease remission and reductions
in itch and oral corticosteroid use compared to placebo in adults
with BP
- BP is a chronic, debilitating, and
relapsing rare skin disease affecting approximately 27,000 adults
in the US whose disease is uncontrolled by systemic
corticosteroids
- Dupixent is now approved in the US
to treat eight distinct diseases with underlying type 2
inflammation, including diseases of the skin, gut, and respiratory
system that affect a broad range of patients, from infants to
elderly people
Paris and Tarrytown, NY, June 20,
2025. The US Food and Drug Administration (FDA) has
approved Dupixent (dupilumab) for the treatment of adult patients
with bullous pemphigoid (BP).
BP primarily affects elderly patients, and is
characterized by intense itch, painful blisters, and lesions, as
well as reddening of the skin. It can be chronic and relapsing with
underlying type 2 inflammation. The blisters and rash can form over
much of the body and cause the skin to bleed and break down,
resulting in patients being more prone to infection and affecting
their daily functioning. Available treatment options are limited
and can add to overall disease burden by suppressing a patient’s
immune system.
Patrick DunnExecutive Director,
International Pemphigus and Pemphigoid Foundation “People affected
by bullous pemphigoid endure unrelenting itch and painful blisters
that can damage the skin. Until now, these primarily elderly
patients have had limited therapeutic options available, with
potential side effects that have often added to their burden. The
approval of Dupixent for bullous pemphigoid brings a novel
treatment approach to patients and their caregivers, and we are
grateful for the tireless efforts of the scientific community who
helped us reach this critical milestone.”
Alyssa Johnsen, MD, PhD Global
Therapeutic Area Head, Immunology and Oncology Development, Sanofi
“Until now, treating bullous pemphigoid was very challenging for
elderly patients struggling with the debilitating impact of
blisters and lesions, and potentially co-morbid conditions. By
addressing two central drivers of the underlying type 2
inflammation that contributes to bullous pemphigoid, Dupixent is
the first targeted medicine to allow patients the potential to
achieve sustained remission and reduce itch. This approval in the
US is important for the thousands of patients living with bullous
pemphigoid, and we look forward to working with regulators around
the world to bring this innovative medicine to more patients in
need.”
The FDA approval is based on data from the
pivotal ADEPT phase 2/3 study that evaluated the efficacy and
safety of Dupixent compared to placebo in adults with
moderate-to-severe BP. Patients were randomized to receive Dupixent
300 mg (n=53) or placebo (n=53) added to standard-of-care oral
corticosteroids (OCS). During treatment, all patients underwent a
protocol-defined OCS tapering regimen if control of disease
activity was maintained. During the FDA review, the analyses were
updated; the FDA-approved results at 36 weeks in the label for
Dupixent compared to placebo are:
- 18.3% of patients experienced
sustained disease remission compared to 6.1% (12.2% difference; 95%
confidence interval: -0.8% to 26.1%), the primary endpoint
- 38.3% of patients achieved clinically
meaningful itch reduction compared to 10.5%
-
Median cumulative OCS dose was 2.8 grams compared to 4.1 grams
In this elderly population, the most common
adverse events (≥2%) more frequently observed in patients on
Dupixent compared to placebo were arthralgia, conjunctivitis,
blurred vision, herpes viral infections, and keratitis.
Additionally, one case of acute generalized exanthematous
pustulosis was reported in one patient treated with Dupixent and
zero patients treated with placebo.
George D. Yancopoulos, MD,
PhDBoard co-Chair, President, and Chief Scientific Officer
at Regeneron “This approval extends the remarkable ability of
Dupixent to transform treatment paradigms for people living with a
variety of diseases with underlying type 2 inflammation, from
common conditions like asthma and atopic dermatitis, to rarer ones
such as eosinophilic esophagitis and prurigo nodularis, and now
including bullous pemphigoid. Dupixent has shown the potential to
improve the most challenging effects of bullous pemphigoid, while
helping some patients achieve sustained disease remission and
decreased oral corticosteroid use. Additionally, this approval
further reinforces the demonstrated safety profile of Dupixent in a
broad age range of patients, from infants to elderly people, and
across dermatological, respiratory, and gastrointestinal
diseases.”
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. Dupixent was previously granted orphan drug designation
by the FDA for BP, which applies to investigational medicines
intended for the treatment of rare diseases that affect fewer than
200,000 people in the US. Additional regulatory applications are
also under review around the world, including in the EU, Japan, and
China.
About the Dupixent BP pivotal
studyADEPT was a randomized, phase 2/3, double-blind,
placebo-controlled study evaluating the efficacy and safety of
Dupixent in 106 adults with moderate-to-severe BP for a 52-week
treatment period. After randomization, patients received Dupixent
or placebo every two weeks after an initial loading dose, along
with OCS treatment. During treatment, OCS taper was initiated after
patients experienced two weeks of sustained control of disease
activity. OCS tapering could start between four to six weeks after
randomization and was continued if disease control was maintained,
with the intent of completion by 16 weeks. After OCS tapering,
patients were only treated with Dupixent or placebo for at least 20
weeks (rescue treatment could be used if required).
The primary endpoint evaluated the proportion of
patients achieving sustained disease remission at 36 weeks.
Sustained disease remission was defined as complete clinical
remission with completion of OCS taper by 16 weeks without relapse
after completion of the OCS taper and no rescue therapy use during
the 36-week treatment period. Relapse was defined as appearance of
≥3 new lesions a month or ≥1 large lesion or urticarial plaque
(>10 cm in diameter) that did not heal within a week. Rescue
therapy could include treatment with high-potency topical
corticosteroids, OCS (including increase of OCS dose during the
taper or re-initiation of OCS after completion of the OCS taper),
or systemic non-steroidal immunosuppressive medications, or
immunomodulating biologics.
Select secondary endpoints evaluated at 36 weeks
included:
- Proportion of patients with
≥4-point reduction in Peak Pruritus Numerical Rating Scale (scale
0-10)
- Total cumulative OCS dose
About DupixentDupixent
(dupilumab) is an injection administered under the skin
(subcutaneous injection) at different injection sites. In adults
with BP, Dupixent 300 mg is administered every other week after an
initial loading dose, and in combination with a tapering course of
oral corticosteroids. Dupixent is intended for use under the
guidance of a healthcare professional and can be given in a clinic
or at home after training by a healthcare professional.
Dupixent 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 two of the key and central
drivers of the type 2 inflammation that plays 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, chronic obstructive pulmonary
disease, and BP in different age populations. More than one million
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 lichen simplex chronicus. 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 Sanofi Sanofi is an R&D driven,
AI-powered biopharma company committed to improving people’s lives
and delivering compelling growth. We apply our deep understanding
of the immune system to invent medicines and vaccines that treat
and protect millions of people around the world, with an innovative
pipeline that could benefit millions more. Our team is guided by
one purpose: we chase the miracles of science to improve people’s
lives; this inspires us to drive progress and deliver positive
impact for our people and the communities we serve, by addressing
the most urgent healthcare, environmental, and societal challenges
of our time.
Sanofi is listed on EURONEXT: SAN and NASDAQ:
SNY.
Sanofi Media RelationsSandrine
Guendoul | +33 6 25 09 14 25 |
sandrine.guendoul@sanofi.com Evan Berland | +1 215
432 0234 | evan.berland@sanofi.comLéo Le Bourhis |
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Rouault | +33 6 70 93 71 40 |
victor.rouault@sanofi.comTimothy Gilbert | +1 516
521 2929 | timothy.gilbert@sanofi.comLéa
Ubaldi | +33 6 30 19 66 46
| lea.ubaldi@sanofi.com
Sanofi Investor RelationsThomas Kudsk
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47 04 12 11 | alize.kaisserian@sanofi.comFelix
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felix.lauscher@sanofi.comKeita Browne | +1 781 249
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Regeneron Media RelationsAnna
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Regeneron Investor RelationsMark
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