Today we’re looking at the latest biologics approved for treating chronic obstructive pulmonary disease (COPD) and any clinical guidelines that are related to them. Currently there are only two biologics approved by the U.S. Food and Drug Administration for COPD: Nucala (mepolizumab) and Dupixent (dupilumab).
Nucala is an interleukin-5 antagonist monoclonal antibody from GlaxoSmithKline. Dupixent is an interleukin-4 receptor alpha antagonist from Regeneron Pharmaceuticals, Inc..
Let’s briefly compare the two drugs.
Biologics for COPD Rundown
| Brand | Generic | Initial Approval | COPD Approval | Indication |
|---|---|---|---|---|
| Nucala | Mepolizumab | November 2015 | May 2025 | As an add-on maintenance treatment of adult patients with inadequately controlled chronic obstructive pulmonary disease (COPD) and an eosinophilic phenotype. |
| Dupixent | Dupilumab | March 2017 | September 2024 | As an add-on maintenance treatment of adult patients with inadequately controlled chronic obstructive pulmonary disease (COPD) and an eosinophilic phenotype. |
While both Dupixent and Nucala were approved roughly 8 and 10 years ago respectively, both drugs were approved for adults with COPD within the past year.
While their COPD approvals align fairly similarly, their other indications vary.
| Condition | Nucala | Dupixent |
|---|---|---|
| Severe Asthma | Yes | Yes |
| Chronic Rhinosinusitis with Nasal Polyps | Yes | Yes |
| Atopic Dermatitis | No | Yes |
| Eosinophilic Granulomatosis with Polyangiitis | Yes | No |
| Eosinophilic Esophagitis | No | Yes |
| Hypereosinophilic Syndrome | Yes | No |
| Bullous Pemphigoid | No | Yes |
| Chronic Spontaneous Urticaria | No | Yes |
| Prurigo Nodularis | No | Yes |
Alongside COPD, Dupixent and Nucala are both approved to treat severe asthma and chronic rhinosinusitis with nasal polyps.
The two biologics differ with a few indications. Nucala is approved for eosinophilic granulomatosis with polyangiitis and hypereosinophilic syndrome, while Dupixent is not. On the other hand, Dupixent is approved for atopic dermatitis, eosinophilic esophagitis, bullous pemphigoid, chronic spontaneous urticaria, and prurigo nodularis, while Nucala is not.
Dupixent and Nucala in Clinical Guidelines
Let’s take a look at a couple of COPD-related clinical guidelines published or updated since Dupixent and/or Nucala were approved by the FDA for COPD for references on clinical guidance that currently exists regarding either drug.
Global Strategy for Prevention, Diagnosis and Management of COPD 2025 Report
- Global Initiative for Chronic Obstructive Lung Disease (GOLD)
- These guidelines were published before Nucala was approved for COPD.
- Dupilumab is mentioned a few times throughout these updated guidelines.
Global Strategy for Asthma Management and Prevention 2025
- Global Initiative for Asthma (GIA)
- There are numerous mentions of both drugs within the guidelines.
We anticipate additional guideline updates to follow as annual updates are processed and taken into consideration.
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