Dupixent becomes one of the most versatile drugs in pharmaceutical history

Overview

Updated May 29

Dupixent was approved for severe eczema in 2017 as a one-disease drug. Nine years later, it's approved for nine conditions, with the latest approval (February 24, 2026) covering allergic fungal rhinosinusitis (AFRS) — which previously had no approved treatment — and reducing the need for additional surgeries and steroid courses by 92% in trials.

The underlying science is what makes Dupixent unusual. Rather than targeting one disease, it blocks interleukin-4 and interleukin-13, immune signaling molecules that drive type 2 inflammation. The same mechanism works across conditions as different as eczema, asthma, food-pipe inflammation, and chronic hives.

Dupixent generated $17.8 billion in global sales in 2025, making it one of the best-selling drugs in the world. But its patents begin expiring around 2031, giving Sanofi and Regeneron a narrowing window to maximize its reach before biosimilar competitors arrive.

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Key Indicators

FDA-approved indications

Number of distinct diseases Dupixent is now approved to treat, the most recent being allergic fungal rhinosinusitis

92%

Reduction in surgery or steroid use

How much Dupixent reduced the need for repeat sinus surgeries or systemic corticosteroid courses versus placebo in the AFRS trial

$17.8B

Global net sales in 2025

Dupixent's annual revenue, up 26% from the prior year, making it one of the highest-grossing drugs worldwide

1.4M+

Active patients worldwide

Number of patients currently being treated with Dupixent across all approved conditions

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People Involved

George D. Yancopoulos

President and Chief Scientific Officer, Regeneron Pharmaceuticals

Leading Regeneron's scientific strategy and Dupixent expansion

Leonard S. Schleifer

Co-founder, Chairman, and former CEO, Regeneron Pharmaceuticals

Serves as executive chairman; co-architect of Regeneron's science-first model

Organizations Involved

Regeneron Pharmaceuticals

Biopharmaceutical partner

Co-developer and co-marketer of Dupixent; 74% of revenue dependent on key biologic drugs

The Tarrytown, New York-based biotech company that discovered dupilumab and co-develops it with Sanofi under a long-standing collaboration agreement.

Sanofi

Pharmaceutical Company

Co-developer and international marketer of Dupixent; projects sales reaching approximately $24 billion by 2030

The Paris-based pharmaceutical giant that co-developed Dupixent with Regeneron and handles its international commercialization.

U.S. Food and Drug Administration

Federal regulatory agency

Has approved Dupixent nine times across distinct indications

The federal agency responsible for evaluating and approving drugs in the United States; has granted Dupixent Priority Review designation for multiple indications including COPD and AFRS.

Timeline

March 2017 February 2026

10 events Latest: February 24th, 2026 · 6 months ago

Tap a bar to jump to that date

February 2026
Ninth FDA approval: allergic fungal rhinosinusitis
Latest Regulatory

The FDA approved Dupixent as the first and only medicine for allergic fungal rhinosinusitis in adults and children aged 6 and older with a history of sinus surgery. The approval was based on a trial showing a 92% reduction in the need for subsequent surgeries and corticosteroid courses.
February 24th, 2026
November 2025
Phase 3 AFRS trial succeeds; FDA accepts Priority Review
Clinical

Sanofi and Regeneron announced that the LIBERTY-AFRS-AIMS Phase 3 trial met all primary and secondary endpoints, and that the FDA accepted a supplemental application for Priority Review with a target date of February 28, 2026.
November 7th, 2025
June 2025
Eighth approval: bullous pemphigoid
Regulatory

The FDA approved Dupixent for bullous pemphigoid, a rare blistering skin disease, making it the only targeted biologic for the condition.
June 20th, 2025
February 2025
Approved for chronic spontaneous urticaria
Regulatory

Dupixent was approved as the first new targeted therapy in over a decade for chronic spontaneous urticaria (chronic hives) in patients aged 12 and older whose symptoms remain uncontrolled by antihistamines.
February 21st, 2025
September 2024
Landmark COPD approval opens largest new market
Regulatory

The FDA approved Dupixent as the first biologic medicine for chronic obstructive pulmonary disease (COPD) with an eosinophilic phenotype, a condition affecting millions of adults. Analysts called 2025 the 'inflection year' for this indication's revenue contribution.
September 27th, 2024
September 2022
Approved for prurigo nodularis
Regulatory

Dupixent gained approval for prurigo nodularis, a chronic skin condition causing intensely itchy nodules, becoming the first FDA-approved treatment for the disease.
September 28th, 2022
May 2022
Approved for eosinophilic esophagitis
Regulatory

The FDA approved Dupixent for eosinophilic esophagitis, a chronic inflammatory condition of the food pipe, making it the first and only treatment for the disease. This marked a significant expansion beyond skin and lung conditions.
May 20th, 2022
June 2019
Third indication: chronic sinusitis with nasal polyps
Regulatory

Dupixent was approved for chronic rhinosinusitis with nasal polyps in adults, its first sinus-related indication and a sign of the drug's expanding relevance to upper-airway inflammatory disease.
June 26th, 2019
October 2018
Second indication: asthma
Regulatory

The FDA approved Dupixent as an add-on maintenance treatment for moderate-to-severe eosinophilic asthma in patients aged 12 and older, establishing the drug's reach beyond skin diseases into the lungs.
October 19th, 2018
March 2017
Dupixent wins first FDA approval for eczema
Regulatory

The FDA approved dupilumab as the first targeted biologic therapy for adults with moderate-to-severe atopic dermatitis (eczema). It was the first drug to block interleukin-4 receptor alpha signaling.
March 28th, 2017

Historical Context

3 moments from history that rhyme with this story — and how they unfolded.

November 1997 - 2011

Rituximab's expansion from cancer to autoimmune disease (1997-2011)

Genentech's Rituxan (rituximab), initially approved for non-Hodgkin lymphoma, was later approved for rheumatoid arthritis, chronic lymphocytic leukemia, and two rare autoimmune conditions. The jump from oncology to autoimmune disease demonstrated that a single biologic could cross major disease category boundaries if the underlying biology supported it.

Then

The rheumatoid arthritis approval in 2006 opened an entirely new commercial market for a drug originally conceived as a cancer treatment.

Now

Rituximab became one of the best-selling drugs in history and established the precedent that biologics could be 'repurposed' across fundamentally different disease categories based on shared immune mechanisms.

Why this matters now

Dupixent's expansion from eczema to COPD to a rare fungal sinus condition mirrors rituximab's leap across disease categories. Both cases demonstrate that when a drug targets the right molecular mechanism, the range of treatable conditions can far exceed initial expectations.

May 2001 - 2016

Gleevec's cancer revolution (2001-2016)

Novartis's Gleevec (imatinib), originally approved for chronic myeloid leukemia, became a landmark in targeted therapy by expanding to treat multiple cancers driven by the same family of malfunctioning enzymes. It earned approvals across ten distinct cancer types or subtypes, transforming the idea that one molecular target could unlock treatments for many diseases.

Then

Gleevec turned chronic myeloid leukemia from a death sentence into a manageable condition, and each new indication validated the targeted-therapy model.

Now

The drug's success inspired an entire generation of precision medicines designed to hit specific molecular drivers across multiple diseases, establishing the template that Dupixent now follows in inflammatory disease.

Why this matters now

Like Gleevec, Dupixent's expansion depends on a single insight: that many apparently different diseases share a common molecular driver. Gleevec proved this model in cancer; Dupixent is proving it in type 2 inflammation.

December 2002 - 2023

Humira's indication expansion (2002-2023)

AbbVie's Humira (adalimumab), a monoclonal antibody targeting tumor necrosis factor, was approved by the FDA in 2002 for rheumatoid arthritis. Over the next two decades, it accumulated approvals for a dozen additional conditions including Crohn's disease, psoriasis, and ulcerative colitis, eventually becoming the best-selling drug in pharmaceutical history with peak annual sales exceeding $21 billion.

Then

Each new indication expanded Humira's patient base and revenue, turning a single arthritis drug into a franchise that dominated AbbVie's finances.

Now

When biosimilars finally arrived in 2023, they rapidly eroded Humira's market share and revenue, demonstrating both the enormous value of multi-indication biologics and the vulnerability that follows patent expiration.

Why this matters now

Dupixent is following a strikingly similar playbook: a single antibody molecule expanding across an ever-growing list of inflammatory conditions. The Humira precedent shows that this strategy can produce decades of market dominance, but also that the patent cliff, when it comes, can be abrupt and severe.