Full Press Release Details
Dupixent late-breaking positive pivotal data in bullous pemphigoid presented at AAD
Paris and Tarrytown, NY, March 8, 2025. Positive results from the pivotal ADEPT
phase 2/3 study evaluating the investigational use of Dupixent (dupilumab) in adults with moderate-to-severe bullous pemphigoid (BP) were shared in a late-breaking oral
presentation at the 2025 American Academy of Dermatology (AAD) Annual Meeting. BP is a chronic, debilitating, and relapsing skin disease with underlying type 2 inflammation and characterized by intense itch and blisters, reddening of the skin, and
Chief of the Division of Dermatology at the Philadelphia Veterans Administration Hospital, Professor of Dermatology
and Medicine at the Hospital of the University of Pennsylvania and the Veteran s Administration Medical Center, and principal investigator of the study
People with bullous pemphigoid live with unrelenting itch, blisters, and painful lesions that can be
debilitating and make it difficult to function daily. Moreover, current treatment options can be challenging for this primarily elderly patient population because they work by suppressing their immune system. By targeting the underlying type 2
inflammation, which is a key driver for bullous pemphigoid, Dupixent is the first investigational biologic to show sustained disease remission and reduce disease severity and itch compared to placebo in a clinical study.
The ADEPT study met all primary and
key secondary endpoints, enrolling 106 adults with moderate-to-severe BP who were randomized to receive Dupixent 300 mg (n=53) every two weeks after an initial loading
dose 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. Sustained disease remission was defined as complete clinical remission with completion of OCS taper by week 16 without relapse and no rescue therapy use during the 36-week
As presented at AAD, results for Dupixent-treated patients at 36 weeks, compared to those treated with placebo, were as
In this elderly population, overall rates of adverse events (AEs) were 96% (n=51) for Dupixent and
96% (n=51) for placebo. AEs more commonly observed with Dupixent compared to placebo in at least 3 patients included peripheral edema (n=8 vs. n=5), arthralgia (n=5 vs. n=3), back pain (n=4 vs. n=2), blurred vision (n=4 vs. n=0), hypertension (n=4
vs. n=3), asthma (n=4 vs. n=1), conjunctivitis (n=4 vs. n=0), constipation (n=4 vs. n=1), upper respiratory tract infection (n=3 vs. n=1), limb injury (n=3 vs. n=2), and insomnia (n=3 vs. n=2). There were no AEs leading to death in the Dupixent
group and 2 AEs leading to death in the placebo group.
In February, the US Food and Drug Administration (FDA) accepted for priority review the supplemental biologics license application for Dupixent to treat BP. The FDA decision is expected by
June 20,2025. 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
applications are also under review around the world, including in the EU.
The safety and efficacy of Dupixent in BP are currently under
clinical investigation and have not been evaluated by any regulatory authority.
BP is a chronic, debilitating, and relapsing skin disease with underlying type 2 inflammation that typically occurs in an elderly population. It is
characterized by intense itch and blisters, reddening of the skin, and painful lesions. The blisters and rash can form over much of the body and cause the skin to bleed and crust, resulting in patients being more prone to infection and affecting
their daily functioning. Approximately 27,000 adults in the US live with BP that is uncontrolled by systemic corticosteroids.
About the Dupixent BP pivotal
ADEPT is 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, 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 as long as
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, unless rescue treatment was 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 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), systemic non-steroidal immunosuppressive medications, or immunomodulating biologics.
Select secondary endpoints
evaluated at 36 weeks included:
Dupixent (dupilumab) 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.
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 chronic obstructive pulmonary disease in different
age populations. More than one million 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.
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, bullous
pemphigoid, 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.
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, Facebook or
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.
EURONEXT: SAN and NASDAQ: SNY
Sanofi Media Relations
Sandrine Guendoul | +33 6 25 09 14 25 | sandrine.guendoul@sanofi.com
Evan Berland | +1 215 432 0234 |
Obrist | +33 6 77 21 27 55 | nicolas.obrist@sanofi.com
L o Le Bourhis | +33 6 75 06 43 81 | leo.lebourhis@sanofi.com
Victor Rouault | +33 6 70 93 71 40 |
Gilbert | +1 516 521 2929 | timothy.gilbert@sanofi.com
Sanofi Investor Relations
Larsen |+44 7545 513 693 | thomas.larsen@sanofi.com
Aliz Kaisserian | +33 6 47 04 12 11 | alize.kaisserian@sanofi.com
Felix Lauscher | +1 908 612 7239 |
Browne | +1 781 249 1766 | keita.browne@sanofi.com
Nathalie Pham | +33 7 85 93 30 17 | nathalie.pham@sanofi.com
Tarik Elgoutni | +1 617 710 3587 |
Ch telet | +33 6 80 80 89 90 | thibaud.chatelet@sanofi.com
Yun Li | +33 6 84 00 90 72 | yun.li3@sanofi.com
Regeneron Media Relations
Ilana Yellen | +1 914-330-9618| ilana.yellen@regeneron.com
Regeneron Investor Relations
| +1 914-847-3482 | mark.hudson@regeneron.com
Sanofi forward-looking statements
contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates regarding
the marketing and other potential of the product, or regarding potential future revenues from the product. Forward-looking statements are generally identified by the words expects , anticipates , believes ,
intends , estimates , plans , and similar expressions. Although Sanofi s management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that
forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from
those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, unexpected regulatory actions or delays, or government regulation generally, that could affect
the availability or commercial potential of the product, the fact that product may not be commercially successful, the uncertainties inherent in research and development, including future clinical data and analysis of existing clinical data relating
to the product, including post marketing, unexpected safety, quality or manufacturing issues, competition in general, risks associated with intellectual property and any related future litigation and the ultimate outcome of such litigation, and
volatile economic and market conditions, and the impact that global crises may have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and on the global
economy as a whole. The risks and uncertainties also include the uncertainties discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under Risk Factors and Cautionary
Statement Regarding Forward-Looking Statements in Sanofi s annual report on Form 20-F for the year ended December 31, 2024. Other than as required by applicable law, Sanofi does not undertake
any obligation to update or revise any forward-looking information or statements.
All trademarks mentioned in this press release are the