# Dupixent Gains FDA Approval for Chronic Spontaneous Urticaria Treatment

## Price Targets from Industry Analysts

• An analyst from BMO Capital set a target price of $903.00 for Dupixent on 03/14/2025.
• Christopher Raymond from Piper Sandler set a target price of $1,195.00 on 11/01/2024.
• Andrew Berens from Leerink Partners set a target price of $880.00 on 11/01/2024.
• Cory Kasimov from Evercore ISI set a target price of $1,170.00 on 10/31/2024.
• Mohit Bansal from Wells Fargo set a target price of $1,050.00 on 10/23/2024.

## Full Release

### FDA Approval of Dupixent

Approval is based on Phase 3 trials showing Dupixent significantly reduces itch and hives compared to placebo.

In the U.S., over 300,000 adults and adolescents aged 12 years and older live with chronic spontaneous urticaria (CSU) but remain symptomatic despite antihistamine treatment.

With this approval, CSU becomes the seventh condition involving type 2 inflammation for which Dupixent is sanctioned.

TARRYTOWN, N.Y., and PARIS, April 18, 2025 (GLOBE NEWSWIRE) — Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi announced that the U.S. Food and Drug Administration (FDA) approved Dupixent
^®
(dupilumab) for treating adults and adolescents aged 12 years and older with chronic spontaneous urticaria (CSU) who remain symptomatic despite H1 antihistamine therapy.

“Patients with chronic spontaneous urticaria suffer from sudden, unpredictable hives and severe itch that severely disrupt their daily lives,” stated Kenneth Mendez, the President and CEO of the Asthma and Allergy Foundation of America. “This approval provides additional treatment options, enabling patients to better manage their condition.”

George D. Yancopoulos, M.D., Ph.D., Board co-Chair, President, and Chief Scientific Officer at Regeneron, remarked, “Dupixent marks the first new targeted treatment for CSU in over a decade. Pivotal trials have shown its effectiveness in significantly reducing the severe itch and unpredictable hives associated with this condition. With this FDA decision, Dupixent is now approved for seven chronic atopic conditions linked to type 2 inflammation, many of which co-occur with CSU, such as atopic dermatitis and asthma. This offers patients a single treatment for multiple atopic diseases. We are eager to provide Dupixent to over 300,000 CSU patients in the U.S. who inadequately respond to conventional treatments.”

### Clinical Trial Basis for Approval

The approval is based on data from two Phase 3 clinical trials—Study A and Study C—encompassing biologic-naïve patients aged 12 and older. These individuals were symptomatic despite antihistamine use and were assessed for Dupixent as an additional therapy compared to antihistamines alone. Both studies achieved their primary and key secondary objectives, demonstrating reductions in itch severity and urticaria activity at 24 weeks. Dupixent also increased the likelihood of achieving controlled disease status compared to placebo over the same period.

Study B provided safety data and examined Dupixent in patients aged 12 and older who were either inadequate responders or intolerant to anti-IgE therapy despite ongoing antihistamine treatment.

Safety results across Study A, Study B, and Study C were aligned with the existing safety profile of Dupixent. In pooled data from these trials, the most frequent adverse event (≥2%) reported in Dupixent patients relative to placebo was injection site reactions.

### Broader Implications for Patients

Alyssa Johnsen, M.D., Ph.D., Global Therapeutic Area Head at Sanofi, expressed, “CSU patients with uncontrolled symptoms endure debilitating itch and hives, profoundly affecting their daily activities. The FDA’s approval of Dupixent presents a significant treatment option to address the underlying causes of severe itching and hives. This medication has the potential to enhance the quality of life for those who have faced few alternatives.”

Dupixent has already received approval for CSU in Japan, the United Arab Emirates, and Brazil. There are ongoing submissions awaiting review by various regulatory authorities, including those in the European Union.

## Understanding Chronic Spontaneous Urticaria

Chronic spontaneous urticaria (CSU) is a chronic inflammatory skin condition fueled in part by type 2 inflammation, leading to sudden, debilitating hives and recurring itch. Patients typically manage CSU with H1 antihistamines—medications that target H1 receptors to alleviate symptoms. However, many patients continue to face uncontrolled symptoms despite antihistamine therapy, leaving them with limited treatment choices. More than 300,000 individuals in the U.S. suffer from CSU inadequately controlled by antihistamines.

## Overview of Dupixent’s Phase 3 Trial Program

The LIBERTY-CUPID Phase 3 trial program evaluating Dupixent for CSU consists of Studies A, B, and C. These randomized, double-blind, placebo-controlled trials investigated the efficacy and safety of Dupixent as an adjunct to standard antihistamine therapy. Studies A and C evaluated patients aged 6 and older who remained symptomatic despite antihistamine use, while Study B included patients aged 12 and older who were inadequate responders or intolerant to anti-IgE treatment. Each trial’s 24-week treatment phase involved an initial loading dose of Dupixent followed by administration every two weeks.

Across the trials, the primary endpoint was the change in itch severity from baseline at 24 weeks. Key secondary endpoints included changes in itch and hive severity as well as proportions of patients achieving well-controlled disease status and complete response.

The results from Studies A and B were published in The Journal of Allergy and Clinical Immunology, while Study B did not achieve its primary endpoint concerning itch reduction at 24 weeks when compared to placebo.

## Key Information About Dupixent

Dupixent is administered via subcutaneous injection at various sites. For adults with CSU who remain symptomatic despite H1 antihistamine treatment, Dupixent is given at a dosage of 300 mg biweekly following an initial loading dose. For patients aged 12 to 17 years with CSU who also remain symptomatic, Dupixent’s dosage is adjusted based on weight, set at 200 mg biweekly.

# Dupixent: New Advancements and Indications for Treatment

Dupixent (dupilumab) can be prescribed in a dosage of 300 mg for adolescents weighing between 30 kg and 60 kg, or for those over 60 kg after an initial loading dose. The medication is recommended for use under the supervision of a healthcare professional, whether administered in a clinical setting or at home following proper training. For adolescents aged 12 to 17 years, caregivers must supervise the treatment.

Developed through Regeneron’s proprietary
VelocImmune



^®


technology, Dupixent is a fully human monoclonal antibody that specifically inhibits interleukin-4 (IL-4) and interleukin-13 (IL-13) pathways, without acting as an immunosuppressant. Clinical trials in Phase 3 revealed significant benefits and a reduction in type 2 inflammation, confirming IL-4 and IL-13 as key contributors to various co-morbid illnesses associated with type 2 inflammation.

Regeneron and Sanofi are dedicated to ensuring that patients in the U.S. prescribed Dupixent have access to this medication, along with the necessary support through the
DUPIXENT



^MyWay


program. For help, patients may contact 1-844-DUPIXENT (1-844-387-4936) or visit

www.DUPIXENT.com

.

Dupixent has received regulatory approvals in over 60 countries for various indications, including treatment for patients with atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyps (CRSwNP), eosinophilic esophagitis (EoE), prurigo nodularis, chronic spontaneous urticaria (CSU), and chronic obstructive pulmonary disease (COPD) across diverse age ranges. Currently, more than 1 million patients are undergoing treatment with Dupixent globally.

¹

Overview of Regeneron’s



VelocImmune



Technology

Regeneron’s
VelocImmune

technology employs a proprietary solution involving a genetically engineered mouse platform that possesses a humanized immune system for producing optimized, fully human antibodies. The concept originated in 1985 when Regeneron co-founder, George D. Yancopoulos, along with his mentor Frederick W. Alt, first envisioned the creation of this genetically humanized mouse. Since then, Regeneron has devoted decades to the innovation and refinement of
VelocImmune

and its related systems, contributing to a significant share of all original, FDA-approved fully human monoclonal antibodies. This category includes Dupixent

^®

(dupilumab), Libtayo

^®

(cemiplimab-rwlc), and others.

Dupilumab Development Progress

Dupilumab is jointly developed by Regeneron and Sanofi under an existing collaboration agreement. It has already been studied through more than 60 clinical trials with over 10,000 patients suffering from various chronic diseases, often linked to type 2 inflammation.

Alongside current approvals, the companies are exploring Dupixent’s efficacy in treating additional diseases associated with type 2 inflammation in ongoing Phase 3 trials. Conditions such as chronic pruritus of unknown origin, bullous pemphigoid, and lichen simplex chronicus are under investigation, though regulatory validation for these uses has not yet occurred.

U.S. Treatment Indications

DUPIXENT is a prescription medicine indicated for:

• Adults and children aged 6 months and above with moderate-to-severe eczema (atopic dermatitis) that is inadequately managed by topical therapies. DUPIXENT can be used with or without topical corticosteroids. Safety and efficacy in children under six months have not been established.
• Adults and children aged 6 years and older for the maintenance treatment of severe eosinophilic or oral steroid-dependent asthma when current therapies are insufficient. DUPIXENT can reduce severe asthma attacks and enhance breathing. Its safety in children with asthma under six years is unverified.
• Adults and children 12 years and older for the maintenance treatment of chronic rhinosinusitis with nasal polyps (CRSwNP). Evidence of safety in children under this age is not known.
• Adults and children aged 1 year and older with eosinophilic esophagitis (EoE), weighing at least 33 pounds (15 kg), with safety not confirmed for those under this weight or age.
• Adults with prurigo nodularis (PN). Its safety in those under 18 years is unproven.
• Adults with uncontrolled chronic obstructive pulmonary disease (COPD) together with other medications to reduce the flare-ups and improve breathing. Safety in children under 18 is unproven.
• Adults and children 12 years and older with chronic spontaneous urticaria (CSU) who do not respond adequately to H1 antihistamines. Its safety in children under 12 years or those under 66 pounds (30 kg) has not been established.

DUPIXENT is not meant for immediate relief of breathing difficulties and does not replace an inhaled rescue medication.

DUPIXENT is not indicated for other types of hives (urticaria).

IMPORTANT SAFETY INFORMATION

Do not use DUPIXENT

if you are allergic to dupilumab or any components of this medication.

B


e


fore starting DUPIXENT, inform your healthcare provider of all medical conditions, especially if you:

• Have any eye-related issues.
• Have records of parasitic (helminth) infections.
• Are due for any vaccinations. Live vaccines should be avoided shortly before and during DUPIXENT treatment.
• Are pregnant or planning to become pregnant.

# Understanding DUPIXENT: Uses, Side Effects, and Important Considerations

## Important Information for Patients

### Pregnancy and Breastfeeding Considerations
If you are pregnant or planning to become pregnant, it’s crucial to inform your healthcare provider. The effects of **DUPIXENT** on an unborn baby are not yet known.

For breastfeeding mothers, it’s also essential to discuss with your healthcare provider, as it’s unclear whether **DUPIXENT** can enter breast milk.

### Medication Disclosure
Make sure to inform your healthcare provider about all medicines you are taking, including prescription drugs, over-the-counter medications, vitamins, and herbal supplements.

Be especially clear if you are using oral, topical, or inhaled corticosteroids, manage asthma with specific medications, or have conditions such as atopic dermatitis, chronic rhinosinusitis with nasal polyps, eosinophilic esophagitis, or chronic spontaneous urticaria among others.

**Do not** adjust or discontinue any of your medications—including corticosteroids or asthma treatments—without consulting your healthcare provider first. Stopping these medications may lead to a resurgence of previously managed symptoms.

## Potential Serious Side Effects of DUPIXENT

**DUPIXENT** can lead to severe side effects, including:

– **Allergic Reactions:** This medication may cause allergic reactions that can be serious. If you experience difficulty breathing, swelling of the face, lips, or throat, fainting, dizziness, a fast pulse, fever, hives, joint pain, general malaise, itching, skin rash, swollen lymph nodes, nausea, or vomiting, seek immediate medical help.

– **Eye Problems:** Inform your healthcare provider about any new or worsening eye issues, such as eye pain or changes in vision. An ophthalmologist may need to examine you if necessary.

– **Vasculitis:** This rare occurrence may affect individuals with asthma using **DUPIXENT**, particularly when tapering off oral steroids. Symptoms to report include rash, chest pain, worsened shortness of breath, dark urine, persistent fever, or sensations of numbness in limbs.

– **Psoriasis:** Some individuals on **DUPIXENT** with atopic dermatitis and asthma may develop psoriasis. Report any new skin symptoms to your healthcare provider, who may refer you to a dermatologist.

– **Joint Pain:** Certain users of **DUPIXENT** have experienced joint issues severe enough to affect mobility, sometimes necessitating hospitalization. Discuss any joint symptoms with your healthcare provider; they may consider stopping the treatment if necessary.

## Common Side Effects to Monitor

Patients taking **DUPIXENT** should be aware of common side effects, which may include:

– **Eczema:** Injection site reactions, inflammation around the eyes, blurred vision, and cold sores are noted.

– **Asthma:** Injection site reactions, eosinophilia, and throat pain can occur.

– **Chronic Rhinosinusitis with Nasal Polyps:** Similar to asthma, but can also include gastritis and joint pain.

– **Eosinophilic Esophagitis:** Side effects may consist of injection site reactions and upper respiratory infections.

– **Prurigo Nodularis:** This can cause eye inflammation and common cold symptoms.

– **Chronic Obstructive Pulmonary Disease (COPD):** Users may report injection site reactions, cold symptoms, and joint pain, among others.

– **Chronic Spontaneous Urticaria:** Only injection site reactions are typically observed here.

If you experience any bothersome or persistent side effects, notify your healthcare provider. Note that this list is not exhaustive. For further guidance on side effects, reach out to your doctor. You are encouraged to report adverse effects to the FDA via their website [www.fda.gov/medwatch](http://www.fda.gov/medwatch) or by calling 1-800-FDA-1088.

## Administration of DUPIXENT

**DUPIXENT** is administered via a subcutaneous injection. Your healthcare provider will determine whether you or a caregiver can give the injection. It is essential that you or your caregiver receive proper training before attempting to prepare and administer **DUPIXENT**.

For children aged 12 years and older, it is recommended that an adult supervise the injection process. Children from 6 months to under 12 years should have the medication administered by a caregiver.

Please refer to accompanying full prescribing information, including patient information.

## About Regeneron

Regeneron (NASDAQ: REGN) stands at the forefront of biotechnology, dedicated to inventing, developing, and commercializing transformative medicines for patients with severe conditions. Founded by physician-scientists, Regeneron’s consistent success in translating scientific advancements into effective therapies has resulted in a range of approved treatments and promising product candidates under development.# Regeneron and Sanofi Collaborate to Advance Innovative Medicines

## Overview of Regeneron’s Contributions

Regeneron Pharmaceuticals is committed to pushing scientific boundaries while advancing drug development. Utilizing proprietary technologies like VelociSuite, the company produces optimized fully human antibodies and novel bispecific antibodies. Regeneron’s pipeline is focused on treating eye diseases, allergies, cancer, cardiovascular issues, metabolic diseases, neurological disorders, hematologic conditions, infectious diseases, and rare diseases.

### Enhancing Medical Insights

Data-powered insights from the Regeneron Genetics Center
^®
have been instrumental in identifying innovative targets for treatment. These pioneering genetic medicine platforms enable the company to shape the next frontier of healthcare, developing potentially transformative therapies.

### Connect with Regeneron

For additional details, visit www.Regeneron.com or follow Regeneron on LinkedIn, Instagram, Facebook, or X.

## About Sanofi

Sanofi is a forward-thinking global healthcare company, dedicated to improving lives through scientific innovation. Sanofi takes pride in providing life-saving vaccines and transformative treatment options to millions worldwide, all while emphasizing sustainability and social responsibility. The company is listed on EURONEXT: SAN and NASDAQ: SNY.

## Important Legal Disclaimers

### Forward-Looking Statements from Regeneron

This press release contains forward-looking statements that involve risks and uncertainties regarding future events and the performance of Regeneron Pharmaceuticals, Inc. (“Regeneron” or the “Company”). Actual outcomes may differ significantly from those projected in these statements. Terms such as “anticipate,” “expect,” “intend,” “plan,” “believe,” and similar expressions are intended to indicate forward-looking statements, though not all such statements will contain these terms.

These statements pertain to several factors, including the timing and success of commercialized products and candidates, such as Dupixent
^®
(dupilumab), intended for the treatment of chronic spontaneous urticaria (CSU). There are inherent uncertainties related to market acceptance, regulatory approval timelines, and manufacturing capabilities that may affect the commercialization of Regeneron’s products.

Other risks include safety issues from the use of Regeneron’s products, potential changes in reimbursement policies from third-party payers, competing products, and public health challenges, along with various legal uncertainties.

Investors should carefully consider these factors, as detailed in Regeneron’s filings with the U.S. Securities and Exchange Commission, including its Form 10-K for the year ended December 31, 2024. Readers are encouraged not to place undue reliance on forward-looking statements, as Regeneron does not undertake any obligation to update these statements following new information or future events.

### Utilizing Digital Media for Communication

Regeneron will continue to leverage its media and investor relations website, as well as social media platforms, to disseminate information that may be relevant to investors. Regular updates regarding financial data and company developments will be provided on these channels.

Sanofi’s Forward-Looking Statements and Market Considerations

 

This press release includes forward-looking statements as defined by the Private Securities Litigation Reform Act of 1995. Forward-looking statements are not historical facts and include projections and estimates about the potential marketing and revenue prospects of the product. Typically, these statements contain words such as “expects,” “anticipates,” “believes,” “intends,” “estimates,” “plans,” and similar phrases. While Sanofi’s management believes these expectations to be reasonable, investors should be aware that numerous risks and uncertainties may cause actual results to differ materially from those stated or implied.

Among the risks are unexpected regulatory actions or delays, which could affect product availability or commercial potential. Additionally, factors such as product commercial success, uncertainties in research and development, future clinical data outcomes, unexpected safety or quality issues, competition, intellectual property challenges, and legal disputes may create further unpredictability. Market volatility and global crises can also impact Sanofi, its customers, suppliers, and overall economic conditions.

For further details regarding risks, investors and stakeholders should consult Sanofi’s public filings with the SEC and AMF, specifically referenced in “Risk Factors” and “Cautionary Statement Regarding Forward-Looking Statements” found in their annual report on Form 20-F for the year ended December 31, 2024. Except as required by law, Sanofi does not intend to update or revise any forward-looking statements.

All trademarks cited in this press release are the property of the Sanofi group, with the exception of VelociSuite and Regeneron Genetics Center.

_______________

¹Data on File

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