Dupixent Approved for Chronic Spontaneous Urticaria
- Food and Drug Management (FDA) has approved Dupixent (dupilumab) for treating adults and adolescents, ages 12 and older, who suffer from chronic spontaneous urticaria (CSU) that remains symptomatic...
- Dupixent is the first new targeted medication approved in the U.S.in over a decade for chronic spontaneous hives.
- The approval was primarily based on Phase III clinical trial results. These studies demonstrated that Dupixent significantly reduced itching and hives compared to a placebo.
FDA Approves Dupixent for Chronic Spontaneous Urticaria
Paris and Tarrytown, N.Y. – April 18, 2025 – The U.S. Food and Drug Management (FDA) has approved Dupixent (dupilumab) for treating adults and adolescents, ages 12 and older, who suffer from chronic spontaneous urticaria (CSU) that remains symptomatic despite treatment with H1 antihistamines.
First Targeted Treatment in a Decade
Dupixent is the first new targeted medication approved in the U.S.in over a decade for chronic spontaneous hives. in the United States, Dupixent is now indicated for more than 300,000 adults and adolescents aged 12 years and older suffering from chronic spontaneous hives (CSU) which remain symptomatic despite antihistamine treatment.
Clinical Trial Success
The approval was primarily based on Phase III clinical trial results. These studies demonstrated that Dupixent significantly reduced itching and hives compared to a placebo.
According to Dr. George D. Yancopoulus, Co-president of the council, President and Scientific Director, Regeneron, pivotal clinical studies have shown that it could contribute to significantly reducing the main symptoms of this disease, which are intense itching and hives. With this FDA decision, Dupixent is now approved for the treatment of seven chronic and disabling atopic diseases caused in part by an underlying type 2 inflammation, several, such as atopic dermatitis and asthma, are frequently enough associated with Spontaneous chronic hives – giving patients access to drugs that could help treat several atopies present simultaneously.
Patient Perspectives
Kenneth Mendez, President and Managing Director of the Asthma and Allergy Foundation of America, stated, “People with spontaneous chronic hives have sudden and unpredictable urticaria, and also frequently enough unbearable itching that weigh heavily on their daily lives. The approval of this drug offers more options to patients and the possibility of controlling their disease.”
Dr. Alyssa Johnsen, Ph.D.,World manager,therapeutic area,development in immunology and oncology,Sanofi,said,”patients with uncontrolled CSU have extremely embarrassing itching and hives plaques that can significantly disturb their daily lives. Approval of the FDA offers them a new therapeutic option that can definitely help remedy the underlying factors of these severe and recurring signs and symptoms. Dupixent has the potential to improve the clinical results of patients who had previously only had access to a limited number of therapeutic options against this disease.”
About the Clinical Studies
The FDA approval was supported by data from two Phase III clinical trials, study A (n=136) and Study C (n=148). These studies involved patients aged 12 and older who remained symptomatic despite antihistamine treatment. Researchers assessed Dupixent along with conventional antihistamine treatment, compared to antihistamines alone. Both studies met their primary and key secondary endpoints. At week 24,Dupixent demonstrated reductions in itch severity and hive activity (a score evaluating both itching and hives) compared to the placebo. Dupixent also increased the likelihood of disease control or complete response by week 24, compared to the placebo.
Study B (n=108) provided additional tolerance data for the medication’s approval and assessed Dupixent in patients aged 12 and older who where refractory or intolerant to anti-IgE treatment and remained symptomatic despite antihistamine use.
Safety Profile
safety results from Studies A, B, and C were generally consistent with Dupixent’s known tolerance profile in its approved indications. The most common adverse events (≥2%) observed in patients treated with Dupixent, compared to placebo, were injection site reactions.
Global Availability
Dupixent is already approved for CSU treatment in Japan, the United Arab Emirates, and Brazil. Regulatory authorities in several other countries, including the European Union, are currently reviewing submissions.
About Chronic Spontaneous Urticaria
Chronic spontaneous urticaria is a chronic inflammatory skin disease caused in part by type 2 inflammation. It is characterized by the sudden appearance of debilitating hives and persistent itching.CSU is typically treated with H1 antihistamines, which target histamine 1 receptors to mitigate hive symptoms. However, many patients remain uncontrolled despite antihistamine treatment and have limited therapeutic options. Consequently, they continue to experience symptoms, including persistent itching and burning sensations, which can significantly impair their quality of life. In the U.S., more than 300,000 people have CSU that is inadequately controlled by antihistamines.
Phase III Program Details
The Phase III LIBERTY-CUPID program evaluated Dupixent in CSU treatment across three studies: Study A, Study B, and Study C. These randomized, double-blind, placebo-controlled clinical trials assessed the efficacy and safety of Dupixent in addition to conventional antihistamine treatment, compared to antihistamine treatment alone. Studies A and C were replicate studies evaluating patients aged six and older who remained symptomatic despite antihistamine use.Study B involved patients aged 12 and older who remained symptomatic despite antihistamine treatment and were refractory or intolerant to anti-IgE. During the 24-week treatment period, patients received an initial loading dose, followed by 300 mg of Dupixent every two weeks, except for children weighing less than 60 kg, who received 200 mg every two weeks.
The primary endpoint in all three studies was the change in itch severity score at week 24, compared to baseline (measured by the weekly pruritus severity score, on a scale of 0 to 21). Key secondary endpoints included the change in itching and hives relative to baseline (weekly hive activity score [UAS7] on a scale of 0 to 42). Other secondary endpoints evaluated the proportion of patients with well-controlled disease (UAS7 score ≤6) and the proportion of patients with a complete response (UAS7 = 0).
Results from Studies A and B were published in The Journal of Allergy and Clinical Immunology. In the U.S.,Study B’s primary endpoint,the reduction in ISS7 score at week 24 compared to placebo,was not met.
About Dupixent
Dupixent (dupilumab) is administered via subcutaneous injection, with alternating injection sites. For adults with CSU who remain symptomatic despite H1 antihistamine treatment,Dupixent 300 mg is administered every other week after an initial loading dose. For patients aged 12 to 17 who remain symptomatic despite H1 antihistamine treatment, Dupixent is administered every other week at a weight-based dose (200 mg for adolescents weighing between 30 and 60 kg, 300 mg for adolescents weighing 60 kg and more), following an initial loading dose. Dupixent should be administered under the supervision of a healthcare professional, at the hospital, or by the patient at home after training. Teenagers aged 12 to 17 must administer Dupixent under adult supervision.
Dupixent is a fully human monoclonal antibody that inhibits the signaling of interleukin-4 (IL-4) and interleukin-13 (IL-13), without immunosuppressive effects. The Phase III clinical development program for Dupixent included studies.
Here’s a Q&A-style blog post about the FDA approval of Dupixent for chronic spontaneous urticaria (CSU), crafted to meet your detailed requirements:
Dupixent for Chronic Spontaneous Urticaria (CSU): your Questions Answered
Are you or a loved one struggling with chronic spontaneous urticaria (CSU)? This condition, also known as chronic hives, can be incredibly frustrating. Fortunately, the FDA has approved a new treatment option: Dupixent (dupilumab). Let’s dive into the details.
What is Chronic Spontaneous Urticaria (CSU)?
Q: What exactly is chronic spontaneous urticaria (CSU)?
A: CSU is a chronic inflammatory skin disease characterized by the sudden appearance of hives (itchy,raised welts) and persistent itching. The term “spontaneous” means the cause isn’t always clear. In part, type 2 inflammation is a cause.
Q: What are the symptoms of CSU?
A: The main symptoms are:
Hives: Raised, itchy welts on the skin that can appear suddenly.
Itching: persistent and often intense itching.
Burning Sensations: Some individuals experience a burning sensation on the skin.
Q: How does CSU impact a person’s life?
A: The symptoms of CSU can significantly impair a person’s quality of life. the itching and hives can be incredibly distracting, leading to sleep disturbances, anxiety, and reduced daily functioning.
Understanding dupixent and its Approval
Q: What is Dupixent, and how does it work for CSU?
A: Dupixent (dupilumab) is a fully human monoclonal antibody.it works by targeting the signaling of interleukin-4 (IL-4) and interleukin-13 (IL-13). These are key proteins involved in inflammation. Dupixent does not have immunosuppressive effects.
Q: Why is the FDA approval of Dupixent significant?
A: The FDA approval of Dupixent is a major step forward for people with CSU.It is the first new targeted medication approved in the U.S. in over a decade for treating this condition.This approval offers a novel therapeutic option for patients whose CSU is not adequately controlled by antihistamines.
Q: Who is eligible to receive Dupixent for CSU?
A: Dupixent is approved for:
Adults and adolescents aged 12 and older.
Those who still experience symptoms despite treatment with H1 antihistamines.
Q: Where can I get more information about Dupixient?
A: You should contact your Doctor or seek professional advice.
Clinical Trial Results
Q: What were the key findings from the clinical trials that supported the FDA approval?
A: The FDA approval was based on the results of Phase III clinical trials, specifically Studies A and C. These studies showed that dupixent, when added to antihistamine treatment:
significantly reduced itch severity compared to a placebo.
reduced hive activity (a measure of both itching and hives).
Increased the likelihood of disease control or a complete response.
Q: Were there any differences in the results between the studies?
A: Study B was used by the FDA to assess tolerance to the medication. In the U.S.,Study B’s primary endpoint,the reduction of ISS7 score at week 24 compared to the placebo,was not met.
Treatment with Dupixent
Q: How is Dupixent administered?
A: Dupixent is administered via a subcutaneous injection (under the skin). Injection sites should be alternated.
Q: What is the dosage for dupixent?
A: The dosage depends on the patient’s age:
Adults: 300 mg every other week, after an initial loading dose.
Adolescents (12-17 years old): Weight-based dose every other week, after an initial loading dose.
200 mg for those weighing between 30 kg (66 lbs) and 60 kg (132 lbs).
300 mg for those weighing 60 kg (132 lbs) or more.
Q: Where is Dupixent administered?
A: Dupixent can be administered under the supervision of a healthcare professional, at the hospital, or by the patient at home after appropriate training. For adolescents (12-17 years old), it must be administered under adult supervision.
Q: What are the most common side effects of Dupixent?
A: The most common adverse event observed in patients treated with Dupixent in the clinical trials was injection site reactions.
Key Takeaways
Q: In a nutshell, what does Dupixent offer for CSU patients?
A: It offers a new, targeted treatment option for individuals with CSU who are not adequately controlled by antihistamines, perhaps leading to:
Reduced itching and hives.
Improved disease control.
* Enhanced quality of life.
Q: Is Dupixent available globally?
A: Dupixent is currently approved for CSU treatment in the United States, Japan, the United Arab Emirates and Brazil. Regulatory authorities in the European Union and several other countries, are currently reviewing submissions.
Summary Table
| Feature | Dupixent (for CSU) |
| ——————- | —————————————————— |
| Mechanism | Monoclonal antibody; inhibits IL-4 and IL-13 signaling |
| Management | Subcutaneous injection |
| Target Population | Adults and Adolescents (12+) with CSU & H1 antihistamine use |
| Key Benefits | Reduced itching and hives, improved disease control |
| Common Side Affect | Injection site reactions |