FDA approves Dupixent for chronic spontaneous urticaria, first targeted therapy in over a decade

Regeneron and Sanofi announced that the U.S. FDA has approved Dupixent (dupilumab) for the treatment of chronic spontaneous urticaria (CSU) in adults and adolescents aged 12 and older who continue to experience symptoms despite antihistamine treatment. This marks the first approval of a new targeted therapy for CSU in over ten years.

The approval is based on results from Phase 3 trials (Studies A and C) that demonstrated significant reductions in itch and hives compared to placebo. These studies also showed increased rates of well-controlled disease and complete response. Study B provided additional safety data in patients who previously had inadequate response or intolerance to anti-IgE therapy.

Key details:
- More than 300,000 people in the U.S. have CSU that remains uncontrolled with antihistamines.
- Dupixent becomes the seventh approved indication for conditions related to type 2 inflammation.
- Safety profile remains consistent, with the most common adverse event being injection site reactions.
- Dupixent is already approved for CSU in Japan, Brazil, and the UAE, with additional reviews underway in other regions.

Dupixent is a fully human monoclonal antibody that inhibits IL-4 and IL-13 signaling, important drivers of type 2 inflammation. It is not classified as an immunosuppressant. It is administered every two weeks via subcutaneous injection and is intended for use under medical guidance.

This new indication expands Dupixent’s use across multiple chronic conditions, including asthma, atopic dermatitis, eosinophilic esophagitis, and nasal polyps. The drug is currently used by over 1 million patients worldwide.

Regeneron’s EYLEA HD 8 mg Receives FDA Priority Review for Expanded Use

Regeneron Pharmaceuticals announced that the U.S. FDA has accepted a supplemental Biologics License Application (sBLA) for EYLEA HD (aflibercept) Injection 8 mg for Priority Review. The review pertains to two key updates: the treatment of macular edema following retinal vein occlusion (RVO) and the option for monthly dosing in all currently approved indications.

If approved, EYLEA HD would become the only treatment for RVO allowing an extended dosing interval of up to every 8 weeks after the initial loading doses. Current anti-VEGF therapies for RVO, including the standard EYLEA 2 mg, are limited to monthly dosing.

The sBLA is supported by the Phase 3 QUASAR trial, which showed that EYLEA HD administered every 8 weeks provided non-inferior visual gains compared to monthly 2 mg dosing. The safety profile was consistent with previous findings, with intraocular inflammation rates and other adverse events remaining low.

The FDA’s decision is expected by August 19, 2025. Regeneron notes that the approval could offer physicians and patients greater flexibility in dosing, potentially reducing treatment burden.

EYLEA HD is already approved in the U.S. for wet AMD, diabetic macular edema (DME), and diabetic retinopathy (DR), and is jointly developed with Bayer. The new indication and dosing flexibility, if approved, would mark another step forward in Regeneron’s ophthalmology portfolio.

**Regeneron and Sanofi’s Dupixent Approved in Japan for COPD, Marking First Biologic Treatment for the Disease**

On March 28, 2025, Regeneron Pharmaceuticals and Sanofi announced that Japan's Ministry of Health, Labour and Welfare has approved Dupixent (dupilumab) for the treatment of chronic obstructive pulmonary disease (COPD) in adults whose disease is not adequately controlled by existing therapies. This approval marks the first-ever biologic medicine authorized in Japan for COPD and follows recent approvals in the U.S., EU, and China.

The decision was based on results from the pivotal Phase 3 BOREAS trial, which demonstrated that Dupixent significantly reduced exacerbations and improved lung function in adults with uncontrolled COPD and elevated eosinophil counts. The trial’s safety profile was consistent with previous Dupixent studies, with the most common adverse event being injection site reactions.

This approval adds COPD as the sixth indication for Dupixent in Japan, where it is also approved for atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis, prurigo nodularis, and chronic spontaneous urticaria.

Dupixent, a fully human monoclonal antibody, blocks interleukin-4 and interleukin-13 signaling and is now approved in over 60 countries across a range of diseases driven by type 2 inflammation. Over one million patients worldwide have been treated with Dupixent to date.

The company also continues to evaluate itepekimab, an IL-33 inhibitor, in two Phase 3 trials for COPD. Regulatory submissions for other Dupixent indications, such as bullous pemphigoid and chronic pruritus, are in progress.

More information is available at [www.regeneron.com](https://www.regeneron.com) and [www.sanofi.com](https://www.sanofi.com).

Regeneron Science Talent Search 2025 Awards More Than $1.8 Million to High School Seniors for Innovative Scientific Research on Classifying Objects in Space, Treating a Rare Muscle Disease and Solving a Long-Standing Math Problem

Regeneron and Sanofi presented positive late-breaking data from the ADEPT Phase 2/3 trial at the American Academy of Dermatology Annual Meeting, demonstrating the effectiveness of Dupixent (dupilumab) in treating moderate-to-severe bullous pemphigoid (BP). The study showed that five times more patients on Dupixent achieved sustained disease remission at 36 weeks compared to placebo. Dupixent also significantly reduced disease severity, itch, and the need for oral corticosteroids.

The trial enrolled 106 adults, with patients receiving Dupixent every two weeks or a placebo alongside standard oral corticosteroids. Key findings at 36 weeks included 20% of Dupixent-treated patients achieving sustained remission versus 4% on placebo, 40% showing a ≥90% reduction in disease severity, and a significant reduction in corticosteroid use. Safety findings were consistent with previous studies, with the most common side effects including peripheral edema, joint pain, and upper respiratory infections.

Regulatory submissions for Dupixent in BP are under review in the U.S. and Europe, with an FDA decision expected by June 20, 2025. If approved, Dupixent would be the first targeted therapy for BP, a chronic and debilitating autoimmune skin disease driven by type 2 inflammation.

Regeneron Pharmaceuticals announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended conditional marketing authorization for linvoseltamab to treat adults with relapsed and refractory multiple myeloma (R/R MM). The treatment is intended for patients who have received at least three prior therapies, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody, and have shown disease progression. A final decision from the European Commission is expected in the coming months.

The recommendation is based on data from the LINKER-MM1 trial, which evaluated linvoseltamab in 282 patients. The U.S. FDA has also accepted a Biologics License Application for review, with a decision expected by July 10, 2025.

Linvoseltamab is a BCMAxCD3 bispecific antibody designed to link MM cells with T cells, facilitating immune response. The treatment regimen includes step-up dosing, transitioning to biweekly and eventually monthly administration for responsive patients.

Multiple myeloma, the second most common blood cancer, remains incurable, with patients often requiring additional therapies. Linvoseltamab is part of a broader clinical development program exploring its use in earlier treatment stages and in combination with other therapies.

Regeneron is leveraging its VelociSuite® technologies to develop innovative blood cancer treatments, focusing on bispecific antibodies and emerging modalities. The company continues to push the boundaries of genetic medicine and antibody development to create transformative treatments.

Regeneron Pharmaceuticals announced that the FDA has accepted the resubmitted Biologics License Application (BLA) for odronextamab, a treatment for relapsed/refractory follicular lymphoma (FL) in patients who have undergone at least two prior systemic therapies. The FDA is expected to make a decision by July 30, 2025.

The acceptance follows the completion of an FDA-mandated enrollment target for the Phase 3 confirmatory trial (OLYMPIA-1). The resubmission is backed by data from Phase 1 and pivotal Phase 2 trials, which showed an 80% overall response rate and a 74% complete response rate. Serious adverse events were reported in 67% of patients, with cytokine release syndrome, COVID-19, and pneumonia being the most common.

Odronextamab is already approved in the European Union under the name Ordspono for treating FL and diffuse large B-cell lymphoma (DLBCL). The drug is being further investigated in multiple trials, including as a monotherapy in Phase 3 trials against standard chemotherapy treatments.

Regeneron continues to expand its hematology portfolio, leveraging its proprietary VelociSuite technology for developing bispecific antibodies and other novel therapies. The company remains committed to advancing innovative treatments for blood cancers and rare blood disorders.

Regeneron Pharmaceuticals announced promising results from its Phase 1/2 CHORD trial for DB-OTO, an investigational gene therapy aimed at treating profound genetic hearing loss caused by otoferlin (OTOF) gene variants. In the trial, 10 of 11 children who received at least one post-treatment assessment showed significant hearing improvements. The first child dosed demonstrated near-normal hearing levels at key speech frequencies and notable speech development over 72 weeks.

The therapy, which uses an intracochlear injection to deliver a functional OTOF gene, was well tolerated, with only transient post-surgical vestibular effects reported. DB-OTO has received multiple designations from the U.S. FDA, including Orphan Drug and Fast Track, but remains under clinical investigation.

The CHORD trial continues to enroll participants in the U.S., U.K., and Spain.

source: Regeneron Pharmaceuticals, February 24, 2025.

Regeneron Reports Fourth Quarter and Full Year 2024 Financial and Operating Results; Initiates Quarterly Dividend and Increases Total Share Repurchase Capacity to ~$4.5 Billion
•Fourth quarter 2024 revenues increased 10% to $3.79 billion versus fourth quarter 2023
•Full year 2024 revenues increased 8% to $14.20 billion versus 2023; excluding RonapreveTM(a)(b), revenues increased 10%
•Fourth quarter 2024 Dupixent® global net sales (recorded by Sanofi) increased 15% to $3.70 billion versus fourth quarter 2023; full year 2024 Dupixent global net sales increased 22% to $14.15 billion versus 2023
•Fourth quarter 2024 U.S. net sales for EYLEA HD® and EYLEA® increased 2% versus fourth quarter 2023 to $1.50 billion, including $305 million from EYLEA HD; full year 2024 U.S. net sales for EYLEA HD and EYLEA increased 1% versus 2023 to $5.97 billion versus 2023, including $1.20 billion from EYLEA HD
•Fourth quarter 2024 Libtayo® global net sales increased 50% to $367 million versus fourth quarter 2023; full year 2024 Libtayo global net sales increased 40% to $1.22 billion versus 2023
•Fourth quarter 2024 GAAP diluted EPS of $8.06 and non-GAAP diluted EPS(a) of $12.07; fourth quarter 2024 includes unfavorable $0.11 impact from acquired IPR&D charge
•Initiation of quarterly cash dividend program, $0.88 dividend declared; additional $3.0 billion share repurchase program authorized, bringing current repurchase capacity to ~$4.5 billion
•Regulatory applications submitted to FDA for EYLEA HD pre-filled syringe, Dupixent in bullous pemphigoid, odronextamab in follicular lymphoma, and linvoseltamab in multiple myeloma
•Positive Phase 3 results reported for EYLEA HD in retinal vein occlusion (RVO) and Libtayo in high-risk adjuvant