What are the most recent new indications for Dupilumab (dupilumab)?

Recent New Indications for Dupilumab

The most recent FDA-approved indications for dupilumab include chronic obstructive pulmonary disease (COPD) with eosinophilic phenotype, chronic spontaneous urticaria (CSU), and bullous pemphigoid (BP), all approved in 2024-2025. 1

Chronological Timeline of Recent Indications

2024-2025 Approvals

1. Chronic Obstructive Pulmonary Disease (September 2024)

   • Add-on maintenance treatment for adult patients with inadequately controlled COPD and an eosinophilic phenotype
   • Not indicated for relief of acute bronchospasm 1

2. Chronic Spontaneous Urticaria (April 2025)

   • For treatment of adults and pediatric patients aged 12 years and older with CSU who remain symptomatic despite H1 antihistamine treatment
   • Not indicated for other forms of urticaria 1

3. Bullous Pemphigoid (June 2025)

   • For treatment of adult patients with bullous pemphigoid 1

4. Updated Chronic Rhinosinusitis with Nasal Polyps (September 2024)

   • Expanded indication as add-on maintenance treatment in adult and pediatric patients aged 12 years and older with inadequately controlled CRSwNP 1

Clinical Evidence Supporting New Indications

Chronic Rhinosinusitis with Nasal Polyps

• Dupilumab significantly improves symptoms and quality of life in CRSwNP patients
• Benefits observed regardless of comorbid asthma or NSAID-exacerbated respiratory disease
• Reduces nasal polyp score, improves SNOT-22 quality of life scores, and significantly improves sense of smell 2
• First choice biologic for CRSwNP patients according to expert consensus 3

Eosinophilic Esophagitis

• Previously approved for adults and pediatric patients aged 1 year and older, weighing at least 15 kg
• Retrospective studies show dupilumab effectively induces symptomatic and histologic remission of esophageal disease
• Reduces need for EoE-directed therapy in patients with concomitant EoE 4
• Phase 2 trials demonstrated significant reduction in symptoms of dysphagia and peak mean eosinophil count 3

COPD with Eosinophilic Phenotype

• Newest respiratory indication for dupilumab
• Specifically for patients with inadequately controlled COPD and an eosinophilic phenotype
• Listed as a recommended biologic for eosinophilic COPD in expert consensus guidelines 3

Chronic Spontaneous Urticaria

• For patients aged 12 years and older who remain symptomatic despite H1 antihistamine treatment
• Specifically limited to chronic spontaneous urticaria, not other forms of urticaria 1

Bullous Pemphigoid

• Most recent indication (June 2025)
• For adult patients with this autoimmune blistering skin disease 1

Patient Selection and Monitoring

Key Considerations for Prescribing

• For CRSwNP: Best for patients with high baseline disease severity, comorbid asthma or atopic dermatitis, and those who haven't benefited from intranasal corticosteroids or surgery 2
• For asthma: Effective for both eosinophilic and type 2 inflammatory phenotypes 3
• For atopic dermatitis: Effective as monotherapy or with concomitant topical corticosteroids 5

Monitoring Requirements

• Monitor for eye symptoms, particularly conjunctivitis and keratitis in atopic dermatitis patients
• Watch for hypersensitivity reactions
• Monitor for eosinophilic conditions, especially when reducing oral corticosteroids 2

Safety Profile Across Indications

• Common adverse effects include injection site reactions, nasopharyngitis, and headache
• Conjunctivitis is more common in atopic dermatitis patients than in respiratory indications
• Treatment-related adverse events are generally mild to moderate 2, 6

Dupilumab's expanding indications reflect its effectiveness in targeting the IL-4/IL-13 pathway central to type 2 inflammation across multiple conditions, providing important therapeutic options for patients with difficult-to-treat inflammatory diseases.