When was Dupixent approved for COPD?
Decision brief
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The FDA has approved Dupixent as an add-on maintenance treatment for adults with inadequately controlled COPD and an eosinophilic phenotype. The decision gives Regeneron and Sanofi a new regulatory catalyst to track for commercial and investor implications.
When was Dupixent approved for COPD? The FDA cleared Dupixent (dupilumab) on September 27, 2024, as add-on maintenance for adults with inadequately controlled COPD and an eosinophilic phenotype—the first U.S. biologic in that setting. BOREAS and NOTUS drove the label with 30% and 34% fewer moderate or severe exacerbations.
Contents10 sections
Key Takeaways
- U.S. COPD approval date: September 27, 2024.
- Indication: add-on maintenance in adults with inadequately controlled eosinophilic COPD.
- BOREAS/NOTUS: 30% and 34% reductions in annualized moderate/severe exacerbations vs placebo.
- Entry criterion used blood eosinophils ≥300 cells/µL on maximal inhaled therapy.
When was Dupixent approved for this COPD use?
Regeneron and Sanofi announced FDA approval on September 27, 2024. Dupixent became the first biologic medicine approved in the U.S. for adults with inadequately controlled COPD and an eosinophilic phenotype.
Wire copy: GlobeNewswire Dupixent COPD approval.
What did BOREAS and NOTUS show?
Both Phase 3 studies tested Dupixent versus placebo in adults on maximal standard-of-care inhaled therapy (nearly all on triple therapy) with blood eosinophils at or above 300 cells per microliter.
- BOREAS: 30% reduction in annualized moderate or severe COPD exacerbations over 52 weeks
- NOTUS: 34% reduction on the same primary endpoint
- Lung-function improvements were also reported versus placebo in the sponsors’ release
Peer-reviewed NOTUS detail is in NEJM (NCT04456673).
How large is the U.S. labeled opportunity?
Sponsors estimate about 300,000 U.S. adults live with inadequately controlled COPD and an eosinophilic phenotype. That figure is a market-sizing claim from the approval release, not an FDA census. Still, it frames why BD teams treat the September 2024 decision as a franchise expansion beyond asthma and atopic dermatitis.
Disease context: COPD coverage on NovaPharmaNews and dupilumab drug profile.
Mechanism and use limits
Dupilumab blocks IL-4 and IL-13 signaling tied to type 2 inflammation. The COPD label is add-on maintenance for the eosinophilic phenotype, not a replacement for inhalers and not a claim for every COPD endotype.
Trial registration for NOTUS: NCT04456673.
How BD teams should track the franchise expansion
Dupixent already held major immunology labels before COPD. The September 27, 2024 decision adds a large respiratory segment where type 2 biology is measurable via blood eosinophils. Commercial models should separate asthma renewals from new COPD starts and watch whether eosinophil thresholds gate real-world use.
EU and China COPD clearances around the same period show a global push, but U.S. formulary timing and inhaler background therapy still control near-term volume. Cite the GlobeNewswire release and NEJM NOTUS paper when diligence teams ask “when was Dupixent approved” for COPD specifically.
What remains unproven
Approval does not prove benefit in COPD without eosinophilic biology. Long-term real-world exacerbation reduction, steroid-sparing effects, and comparative value versus other biologics still need post-marketing evidence. EU and China approvals around the same period should be tracked separately from the U.S. September 27, 2024 date.
Related NovaPharma coverage
Frequently Asked Questions
When was Dupixent approved for COPD in the U.S.?
On September 27, 2024, the FDA approved Dupixent (dupilumab) as an add-on maintenance treatment for adults with inadequately controlled COPD and an eosinophilic phenotype. It was the first U.S. biologic approved for that COPD population.
What Phase 3 data supported the COPD approval?
BOREAS and NOTUS enrolled adults on maximal inhaled therapy with blood eosinophils ≥300 cells/µL. Dupixent cut the annualized rate of moderate or severe exacerbations by 30% (BOREAS) and 34% (NOTUS) versus placebo over 52 weeks.
Who is the labeled COPD population?
Adults with inadequately controlled COPD and an eosinophilic phenotype, used as add-on maintenance. Sponsors estimate about 300,000 U.S. adults fit that profile. It is not approved as monotherapy for all COPD phenotypes.
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