Drug Update · Pulmonology

dupilumab: FDA Approves for COPD; FEV1 Improved 0.09 L in BOREAS

July 10, 2026

Drug

dupilumab (Dupixent)

FDA indication

Add-on maintenance treatment for adult patients with inadequately controlled COPD and an eosinophilic phenotype [11]

Label effective date

2026-04-22 [11]

Trial

BOREAS (phase 3) [6][5]

Key numeric efficacy

Pre-bronchodilator FEV1 improvement 0.09 L (95% CI 0.04-0.14) [6]

Dose (FDA-approved, COPD)

300 mg every 2 weeks (Q2W) subcutaneous [11]

Clinical Perspective

This update affects pulmonologists, allergy/immunology specialists, primary care clinicians, and pharmacists treating adult patients with COPD characterized by an eosinophilic phenotype, per the FDA label ^[4]. The source data support dupilumab as an add-on maintenance option for patients with inadequately controlled COPD and type 2 inflammation, with trial-reported benefits in exacerbation outcomes and an improvement in pre-bronchodilator FEV1 of 0.09 L at Week 12 ^[3]^[2]. A remaining clinical question is which patient selection criteria (beyond the eosinophil threshold) will best predict long-term clinical benefit and health-resource outcomes with dupilumab in COPD?

Dr. Nikhil Chatterjee, MBBS, MD (Respiratory Medicine) · Pulmonology

Dupilumab (Dupixent) was approved by the U.S. Food and Drug Administration as an add-on maintenance treatment for adult patients with inadequately controlled chronic obstructive pulmonary disease (COPD) and an eosinophilic phenotype, with the most recent label revision effective 2026-04-22 ^[4]. The approval referenced data from the phase 3 BOREAS trial, which demonstrated reductions in exacerbations and an improvement in pre-bronchodilator FEV1 of 0.09 L (95% CI 0.04-0.14) versus placebo in analyses reported from the trial program ^[3]. Clinicians should consult current prescribing information for complete dosing guidance.

Clinical Context

Dupilumab is a human monoclonal IgG4 antibody that specifically binds to the interleukin-4 receptor alpha (IL-4Rα) subunit, inhibiting IL-4 and IL-13 signaling; the mechanism is described in the prescribing information ^[4]. Dupilumab (Dupixent) is manufactured by Sanofi and Regeneron and already has multiple FDA indications including atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis, eosinophilic esophagitis, prurigo nodularis, chronic spontaneous urticaria, bullous pemphigoid, and allergic fungal rhinosinusitis per the label ^[4]^[1]. The COPD approval expands use into chronic airway disease for patients with an eosinophilic phenotype, and the FDA decision referenced the BOREAS phase 3 trial program in which dupilumab was evaluated as add-on therapy to maximal inhaled treatment in patients with type 2 inflammation ^[4]^[3].

Key Findings

The BOREAS trial program showed dupilumab reduced COPD exacerbations and improved lung function; pre-bronchodilator FEV1 change from baseline at Week 12 included a between-group improvement of 0.09 L (95% CI 0.04-0.14) with dupilumab versus placebo in analyses reported from the trial program ^[3].
In subgroup analyses by baseline BODE index reported from the BOREAS program, exacerbation reductions were observed across groups: relative risk (95% CI) for annualized moderate or severe exacerbations was 0.656 (0.496-0.868) in patients with BODE index >4 and 0.718 (0.547-0.944) in patients with BODE index ≤4, indicating similar reductions by BODE index subgroup in the published analysis ^[2].
The trial program enrolled patients with COPD and type 2 inflammation defined by screening blood eosinophils ≥300 cells/µL and assessed annualized moderate/severe COPD exacerbation rates over 52 weeks and changes in pre-bronchodilator FEV1 at Weeks 12 and 52 as key outcomes ^[3]^[2].

Safety & Tolerability

Injection site reactions ^[1]
Herpes simplex virus infections ^[1]
Common cold ^[1]
Muscle pain ^[1]
Diarrhea ^[1]
Throat pain ^[1]
Allergic reactions ^[1]
Eye problems ^[1]
Inflammation of blood vessels ^[1]
Joint aches and pain ^[1]

Study Design

The BOREAS trial was a phase 3 randomized, double-blind, placebo-controlled trial program in patients with COPD and type 2 inflammation (screening blood eosinophils ≥300 cells/µL) on maximal inhaled therapy; patients were randomized to add-on dupilumab 300 mg or placebo every 2 weeks for 52 weeks and were assessed for annualized moderate/severe COPD exacerbation rates and change in pre-bronchodilator FEV1 at Weeks 12 and 52 ^[3]^[2]. Clinicians should consult current prescribing information for full dosing guidance. The FDA approved dupilumab for COPD as an add-on maintenance treatment for adult patients with inadequately controlled COPD and an eosinophilic phenotype, with the most recent label revision effective 2026-04-22 ^[4].

FAQ

Q1 What is dupilumab (Dupixent) approved for in COPD?

Dupixent (dupilumab) is approved by the FDA as an add-on maintenance treatment for adult patients with inadequately controlled chronic obstructive pulmonary disease (COPD) and an eosinophilic phenotype, per the prescribing information with a label effective date of 2026-04-22. The approval references results from the phase 3 BOREAS trial program evaluating add-on dupilumab in patients with type 2 inflammation.

Q2 How does dupilumab work?

Dupilumab is a human monoclonal IgG4 antibody that binds specifically to the interleukin-4 receptor alpha (IL-4Rα) subunit, blocking IL-4 signaling via the Type I receptor and both IL-4 and IL-13 signaling via the Type II receptor, thereby inhibiting IL-4- and IL-13-mediated inflammatory responses; this mechanism is described in the FDA prescribing information.

Q3 What is the recommended dose of dupilumab for COPD?

The FDA prescribing information lists the recommended dosage for adult patients with COPD as 300 mg given every 2 weeks (Q2W) administered by subcutaneous injection. Clinicians should consult current prescribing information for complete dosing guidance.

Q4 What are the side effects of dupilumab reported in the sources?

Across FDA materials and trial summaries, reported adverse events include injection site reactions, herpes simplex virus infections, common cold, muscle pain, diarrhea, throat pain, and more serious events described in labeling such as allergic reactions, eye problems, inflammation of blood vessels, and joint aches and pain. Specific adverse-event rates and COPD-specific safety data were reported in the BOREAS program publications and are available in the prescribing information and trial reports.

Clinicians should consult current prescribing information for full dosing guidance.

dupilumab: FDA Approves for COPD; FEV1 Improved 0.09 L in BOREAS

dupilumab: FDA Approves for COPD; FEV1 Improved 0.09 L in BOREAS

Clinical Perspective

Clinical Context

Key Findings

Safety & Tolerability

Study Design

FAQ

References

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