Regeneron and Sanofi Report Positive Dupixent Results for Bullous Pemphigoid

March 08, 2025 (GLOBE NEWSWIRE) — Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi recently shared favorable findings from the pivotal ADEPT Phase 2/3 trial. This trial investigates Dupixent

^®
(dupilumab) for treating adults with moderate-to-severe bullous pemphigoid (BP). The results were unveiled during a late-breaking oral presentation at the 2025 American Academy of Dermatology (AAD) Annual Meeting. BP is a chronic and debilitating skin condition marked by intense itching, blisters, reddening of the skin, and painful lesions due to underlying type 2 inflammation.

“Patients with bullous pemphigoid experience continuous itching, blisters, and painful lesions that significantly impact their daily lives. Current treatments can be complex for this mainly elderly demographic, as they typically suppress the immune system,” remarked Dr. Victoria Werth, Chief of Dermatology at the Philadelphia Veterans Administration Hospital and principal investigator of the study. “Dupixent targets the root cause of BP inflammation, making it the first investigational biologic to demonstrate sustained disease remission and reduced severity and itching compared to placebo in a clinical setting.”

Details of the ADEPT Trial

The ADEPT trial successfully met all its primary and critical secondary benchmarks, enrolling 106 adults with moderate-to-severe BP. Participants were randomly assigned to receive either Dupixent 300 mg (n=53) every two weeks following an initial loading dose or placebo (n=53), in conjunction with standard-of-care oral corticosteroids (OCS). All patients followed a protocol-defined OCS tapering schedule if they maintained disease control. Sustained disease remission was classified as complete clinical remission, tapering off OCS by week 16 without relapse, and no necessity for rescue therapy throughout the 36-week treatment duration.

As highlighted at the AAD meeting, Dupixent-treated patients at the 36-week mark showed the following results compared to placebo:

• 20% achieved sustained disease remission, the primary endpoint, versus 4% for placebo (p=0.0114).
• 40% experienced a ≥90% reduction in disease severity compared to 10% (p=0.0003).
• 40% had a clinically meaningful reduction in itch versus 11% (p=0.0006).
• Cumulative OCS exposure was reduced by an average of 1678 mg (p=0.0220), with a 54% lower risk of requiring rescue medication (p=0.0016).

In this elderly cohort, the overall rate of adverse events (AEs) was 96% (n=51) for both Dupixent and placebo. Notable AEs reported more frequently in the Dupixent group included peripheral edema (n=8 vs. n=5), arthralgia (n=5 vs. n=3), back pain (n=4 vs. n=2), and several others. Importantly, there were no deaths related to AEs in the Dupixent group, whereas the placebo group had two fatal AEs.

FDA Review and Global Applications

This past February, the U.S. Food and Drug Administration (FDA) accepted the supplemental Biologics License Application for Dupixent’s Priority Review for treating BP. A decision from the FDA is anticipated by June 20, 2025. Dupixent has previously received Orphan Drug Designation from the FDA for BP, applicable to medicines meant for rare diseases affecting fewer than 200,000 individuals in the U.S. Additional applications for Dupixent are also under review internationally, including in the European Union.

The safety and efficacy of Dupixent for BP are still under clinical investigation and await evaluation by regulatory authorities.

Understanding Bullous Pemphigoid

Bullous pemphigoid is a chronic, debilitating skin condition that frequently arises in older adults. Characterized by severe itch and blistering, the disease often entails significant skin damage, increasing the risk of infections and hindering daily activities. Approximately 27,000 adults in the U.S. grapple with BP that remains uncontrolled despite systemic corticosteroid treatments.

About the Dupixent BP Pivotal Trial

ADEPT is designed as a randomized, Phase 2/3, double-blind, placebo-controlled trial assessing Dupixent’s efficacy and safety over a 52-week period in 106 adults with moderate-to-severe BP. Patients were randomized to receive Dupixent or placebo biweekly along with OCS treatment. OCS taper began after two weeks of stable disease control and aimed for completion by 16 weeks, provided disease remained controlled. The treatment could continue for at least 20 weeks following OCS taper, barring the need for rescue intervention.

The primary endpoint sought the percentage of patients achieving sustained disease remission at 36 weeks. This was defined as complete clinical remission, successful OCS taper by 16 weeks, and no relapse or use of rescue therapy during the treatment period. Relapse was indicated by the emergence of three new lesions within a month or by significant lesions that persisted without healing for a week. Rescue therapy could include high-potency topical corticosteroids or systemic immunosuppressive medications.

Select secondary endpoints evaluated at 36 weeks included:

• Proportion of patients achieving a ≥90% reduction in the Bullous Pemphigoid Disease Area Index (BPDAI; scale: 0-360)
• Proportion of patients with a ≥4-point reduction in Peak Pruritus Numerical Rating Scale (PP-NRS; scale: 0-10)
• Total cumulative OCS dosage
• Time to first rescue medication usage

About Dupixent

Dupixent, developed using Regeneron’s proprietary VelocImmune^® technology, is a fully human monoclonal antibody that blocks the signaling of interleukin-4 (IL-4) and interleukin-13 (IL-13) pathways. Notably, it is not an immunosuppressant. The development program for Dupixent has demonstrated significant clinical improvements and a reduction in type 2 inflammation during Phase 3 trials, confirming the role IL-4 and IL-13 play in various related diseases.

Dupixent enjoys regulatory approvals in over 60 countries for several indications, including particular cases of atopic dermatitis (AD), asthma, chronic rhinosinusitis with nasal polyps (CRSwNP), eosinophilic esophagitis (EoE), prurigo nodularis (PN), chronic spontaneous urticaria (CSU), and chronic obstructive pulmonary disease (COPD) across diverse age groups. More than 1,000,000 patients are currently receiving treatment with Dupixent worldwide.

About Regeneron’s

Regeneron’s VelocImmune Technology Advances Dupilumab Development

Introduction to VelocImmune Technology

Regeneron’s VelocImmune technology employs a proprietary mouse platform that features a genetically humanized immune system, allowing for the creation of highly optimized fully human antibodies. The concept for this groundbreaking technology originated in 1985 when Regeneron co-founder, President, and Chief Scientific Officer George D. Yancopoulos collaborated with his mentor, Frederick W. Alt, as graduate students. Over the years, Regeneron has dedicated itself to the invention and development of VelocImmune and associated VelociSuite^® technologies.

Yancopoulos and his team have utilized VelocImmune technology to develop a significant portion of FDA-approved fully human monoclonal antibodies. Notable products resulting from this technology include Dupixent^® (dupilumab), Libtayo^® (cemiplimab-rwlc), Praluent^® (alirocumab), Kevzara^® (sarilumab), Evkeeza^® (evinacumab-dgnb), Inmazeb^® (atoltivimab, maftivimab, and odesivimab-ebgn), and Veopoz^® (pozelimab-bbfg). The FDA also authorized REGEN-COV^® (casirivimab and imdevimab) during the COVID-19 pandemic with approval extending until 2024.

Dupilumab Development Program

Dupilumab is under joint development by Regeneron and Sanofi, guided by a global collaboration agreement. To this date, dupilumab has been evaluated in more than 60 clinical trials, involving over 10,000 patients with chronic diseases associated with type 2 inflammation.

Beyond currently approved indications, Regeneron and Sanofi are exploring dupilumab’s effectiveness for additional conditions related to type 2 inflammation and other allergic responses in Phase 3 trials. These conditions include chronic pruritus of unknown origin, bullous pemphigoid, and lichen simplex chronicus. It is important to note that the safety and efficacy of dupilumab for these uses have not yet been fully assessed by regulatory authorities.

U.S. Indications for Dupixent

DUPIXENT is prescribed for the following conditions:

• Adults and children ages 6 months and older with moderate-to-severe eczema (atopic dermatitis) that is not well-managed with topical therapies or when these therapies are inappropriate. DUPIXENT may be used alone or alongside topical corticosteroids. Its safety and efficacy in children under 6 months are not established.
• For adults and children ages 6 and older with moderate-to-severe eosinophilic or oral steroid-dependent asthma who do not achieve control with current medications. DUPIXENT can help prevent severe asthma attacks and may reduce the need for oral corticosteroids. Its safety and efficacy in children under 6 years have not been established.
• For the maintenance treatment of chronic rhinosinusitis with nasal polyps in adults and children ages 12 and older. Safety and efficacy for children under 12 years are not established.
• Adults and children ages 1 and older with eosinophilic esophagitis, weighing at least 33 pounds (15 kg). Safety and efficacy for children under 1 year or who weigh less than 33 pounds have not been established.
• Adults with prurigo nodularis (PN). Safety and efficacy in children under 18 years are not established.
• For adults with inadequately controlled chronic obstructive pulmonary disease (COPD) with elevated blood eosinophils. DUPIXENT reduces flare-ups and can enhance breathing. Safety and efficacy for children under 18 years are not established.

DUPIXENT does not provide immediate relief for sudden breathing problems and is not a substitute for an inhaled rescue medication.

Important Safety Information

Do not use DUPIXENT if allergic to dupilumab or any of its ingredients.

Before Using DUPIXENT, Consider the Following Health Conditions:

• Eye issues.
• Current parasitic (helminth) infections.
• Upcoming vaccinations. Avoid receiving “live vaccines” shortly before and during DUPIXENT treatment.
• If you are pregnant or planning to become pregnant.

Concerns About DUPIXENT Usage: Effects on Pregnant and Nursing Mothers

Patients should be aware that the safety of DUPIXENT during pregnancy is not established. Furthermore, it is currently unknown if DUPIXENT is excreted in breast milk, which raises similar concerns for breastfeeding mothers.

It is important to inform your healthcare provider about all medications you are taking. This includes both prescription and over-the-counter drugs, as well as vitamins and herbal supplements.

Crucial Medicines to Discuss with Your Provider

Specifically, notify your healthcare provider if you are using any oral, topical, or inhaled corticosteroid medications, have asthma requiring treatment, or are dealing with conditions such as atopic dermatitis, chronic rhinosinusitis with nasal polyps, eosinophilic esophagitis, prurigo nodularis, or chronic obstructive pulmonary disease along with asthma.

It is vital not to change or discontinue your other medications, including corticosteroids or asthma medicines, without first consulting your healthcare provider. Abrupt changes may lead to a return of controlled symptoms.

Potential Serious Side Effects of DUPIXENT

DUPIXENT may lead to serious side effects, including:

• Allergic Reactions: Patients should stop using DUPIXENT and seek immediate medical assistance if they experience symptoms such as breathing difficulty, facial swelling, dizziness, fevers, hives, or abdominal cramps.
• Eye Problems: Report any new or worsening eye issues like pain or blurred vision to your healthcare provider. An examination by an ophthalmologist may be necessary.
• Blood Vessel Inflammation: This rare condition has been seen in asthmatics on DUPIXENT who are discontinuing corticosteroids. Patients should alert their healthcare provider if they notice a rash, chest pain, shortness of breath, or persistent fever.
• Joint Pain: Some patients experience joint issues that may hinder mobility and could lead to hospitalization. Any new or worsening joint symptoms should be communicated to a healthcare provider.

Common Side Effects Associated with DUPIXENT

The most frequently reported side effects of DUPIXENT can include the following:

• Eczema: Injection site reactions, eye inflammation (redness, swelling), cold sores, and elevated eosinophil counts may occur.
• Asthma: Similar injection site reactions along with throat pain and potential parasitic infections have been noted.
• Chronic Rhinosinusitis with Nasal Polyps: Injection site reactions, eye inflammation, elevated eosinophils, gastritis, joint pain, insomnia, and toothache may also be experienced.
• Eosinophilic Esophagitis: Commonly reported symptoms include injection site reactions, upper respiratory infections, cold sores, and joint pain.

Patients using DUPIXENT should maintain open communication with their healthcare provider to ensure safety and proper management of any potential side effects.

# Understanding Side Effects and Usage of DUPIXENT in Patients

## Side Effects of DUPIXENT

### Prurigo Nodularis
Patients using DUPIXENT may experience eye and eyelid inflammation. Symptoms include redness, swelling, itching, and sometimes blurred vision. Other common side effects encompass herpes virus infections, nasopharyngitis (common cold symptoms), dizziness, muscle pain, and diarrhea.

### Chronic Obstructive Pulmonary Disease
For individuals with Chronic Obstructive Pulmonary Disease, reported side effects after using DUPIXENT include injection site reactions and common cold symptoms. Additionally, patients may experience eosinophilia (high count of certain white blood cells), viral infections, back pain, rhinitis (inflammation inside the nose), diarrhea, gastritis, joint pain (arthralgia), toothache, headache, and urinary tract infections.

It is important to notify your healthcare provider about any bothersome or persistent side effects you encounter. While this list includes many possible side effects, it does not represent all. For medical advice regarding side effects, please consult your doctor. You are encouraged to **[report](https://www.pivotandflowdaily.com)** adverse effects from prescription drugs to the FDA by visiting **[www.fda.gov/medwatch](http://www.fda.gov/medwatch)** or calling 1-800-FDA-1088.

## Proper Administration of DUPIXENT

DUPIXENT should be used strictly as prescribed by your healthcare provider. This medication is administered via a subcutaneous injection. Clinicians will determine whether you or your caregiver can perform the injection.

**Important:** Do not attempt to prepare or inject DUPIXENT without appropriate training from your healthcare provider. For children aged 12 years and older, the injection should be done by an adult or under adult supervision. In younger children, aged six months to less than 12 years, a caregiver must provide the injection.

## Company Overview and Commitment

### About Regeneron
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) is a leading biotechnology company focused on creating and commercializing innovative medicines for serious medical conditions. Founded by physician-scientists, Regeneron’s consistent success in translating science into therapeutic solutions has resulted in multiple approved treatments and a robust pipeline of product candidates. The company develops therapies for a wide range of health issues including eye diseases, allergic conditions, cancers, cardiovascular diseases, and rare diseases.

Utilizing proprietary technologies like **VelociSuite**, which optimizes fully human antibodies and introduces new bispecific antibodies, Regeneron is at the forefront of scientific advancement. The company leverages insights from the Regeneron Genetics Center® and its pioneering genetic medicine platforms to identify new treatment targets and approaches, contributing to potential cures for various diseases.

For more details, visit **[www.Regeneron.com](http://www.Regeneron.com)** or follow Regeneron on **LinkedIn**, **Instagram**, **Facebook**, and **X**.

### About Sanofi
Sanofi is a global healthcare innovator committed to enhancing lives through scientific advancements. The organization emphasizes transforming medicine practices and offers significant treatment options and vaccines to millions of people worldwide while prioritizing sustainability and social responsibility.

Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY.

## Forward-Looking Statements

This press release contains forward-looking statements that involve risks and uncertainties related to future events and the performance of Regeneron. Actual outcomes may differ significantly based on various factors, including the nature and success of products marketed by Regeneron and its collaborators. Words like “anticipate,” “expect,” “intend,” and other similar expressions mark these statements. They may concern ongoing research, clinical programs, and potential regulatory approvals, particularly relating to Dupixent (dupilumab) for various conditions. The company alerts listeners to the potential challenges in product success, manufacturing, and regulatory compliance.

Regeneron and Sanofi Address Risks and Forward-Looking Statements

Risks Affecting Regeneron’s Future

Regeneron Pharmaceuticals faces multiple administrative and regulatory hurdles that could impede its development and commercialization efforts for both existing products and product candidates. Key concerns include stringent regulatory obligations that impact ongoing clinical programs, particularly those related to patient privacy. Furthermore, the availability and degree of reimbursement for Regeneron’s products from various third-party payers—including private health insurers, health maintenance organizations, and government programs like Medicare and Medicaid—pose additional risks.

Determinations regarding coverage and reimbursement from payers interlace with any new policies and procedures they may set. Additionally, changes in healthcare laws, regulations, and policies may influence the market landscape, contributing to uncertainties. Regeneron also faces competitive threats from other drugs and products that may prove more effective or cost-efficient, particularly as biosimilar versions of Regeneron’s drugs emerge in the industry.

Moreover, the replicability of results from Regeneron’s research and development initiatives is critical. Success in translating these results into clinical trials or securing regulatory approvals can be unpredictable. The company must also navigate unexpected expenses and manage the costs associated with developing, producing, and marketing its products. Any deviation from its financial forecast or the underlying assumptions can significantly impact financial projections.

Furthermore, collaboration and supply agreements—such as those with Sanofi and Bayer—may be subject to cancellation or termination, further complicating Regeneron’s strategic outlook. Public health crises, including outbreaks and pandemics, could disrupt business operations. Legal proceedings, including investigations by the U.S. Department of Justice, add another layer of risk related to litigation and intellectual property issues, exemplified by current proceedings surrounding EYLEA® (aflibercept) Injection.

For a comprehensive overview of these risks, refer to Regeneron’s filings with the U.S. Securities and Exchange Commission. Notably, its Form 10-K for the year ending December 31, 2024, provides further insights. The company’s management cautions that forward-looking statements are made based on current beliefs and should not be solely relied upon, as future updates may occur at Regeneron’s discretion.

Sanofi’s Perspective on Forward-Looking Statements

This press release also includes forward-looking statements as outlined by the Private Securities Litigation Reform Act of 1995. Such statements are characterized as projections or estimates about product marketing and potential future revenues. Words like “expects,” “anticipates,” “believes,” and “plans” typically identify these statements.

While Sanofi’s management considers these forward-looking statements reasonable, they come with uncertainties. Risks such as unforeseen regulatory actions, the success of product sales, and the inherent uncertainties in research and development can result in actual outcomes deviating from projected ones. Moreover, competitive factors, intellectual property risks, and impacts from global crises must be taken into account.

Key uncertainties surrounding these statements are additionally detailed in Sanofi’s public filings with the SEC, specifically in the “Risk Factors” and “Cautionary Statement Regarding Forward-Looking Statements” sections of its annual report on Form 20-F for the year ending December 31, 2024. Sanofi does not commit to revising its forward-looking information unless legally mandated.

All trademarks mentioned in this press release belong to the Sanofi group, excluding VelociSuite and Regeneron Genetics Center.

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