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Sanofi and Regeneron's Dupixent to treat chronic spontaneous urticaria advances in EU with positive
Paris and Tarrytown, September 22, 2025. The European Medicines Agency's Committee for
Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the approval of Dupixent (dupilumab) in the EU for the treatment of chronic spontaneous urticaria (CSU) in adults and adolescents. This recommendation covers those
aged 12 years and above with moderate to severe disease, with inadequate response to histamine-1 antihistamines (H1AH), and who are naive to anti-immunoglobulin E (IgE) therapy. A final decision is expected in
The positive CHMP opinion is supported by data from two studies in the LIBERTY-CUPID phase 3 program (NCT04180488; Study A and Study
C), both of which demonstrated Dupixent significantly reduced itch and hives at 24 weeks compared to placebo. A third study from the LIBERTY-CUPID program, Study B, conducted in a different CSU patient population, provided additional safety data.
The safety results of the studies were generally consistent with the known safety profile of Dupixent in its approved indications. Adverse events more
commonly observed with Dupixent ( 5%) than placebo in the studies of adults and adolescents with CSU were injection site reaction, COVID-19, hypertension,
CSU, and accidental overdose.
Dupixent is approved for CSU in certain adults and adolescents in several countries including Japan and the US.
Outside of approved jurisdictions, the safety and efficacy of Dupixent for CSU has not been fully evaluated by any regulatory authority.
CSU is a chronic, inflammatory skin disease driven in part by type 2 inflammation, which causes sudden and debilitating hives and recurring itch. CSU
is typically treated with H1AH, medicines that target H1 receptors on cells to control symptoms of itch and urticaria. However, the disease remains uncontrolled despite H1AH treatment in many patients, some of whom are left with limited alternative
treatment options. These individuals continue to experience symptoms that can be debilitating and significantly impact their quality of life.
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, CSU, chronic obstructive pulmonary disease, and bullous pemphigoid in different age populations. More than one million patients are being treated with
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 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.
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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.
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Agency's Committee for Medicinal Products for Human Use discussed in this press release on the potential approval by the European Commission of Dupixent for the treatment of chronic spontaneous urticaria ("CSU"); the likelihood,
timing, and scope of possible regulatory approval and commercial launch of Regeneron's Product Candidates and new indications for Regeneron's Products, such as Dupixent for the treatment of CSU in the European Union as discussed in this
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