FDA Approves Dupixent (dupilumab) for Allergic Fungal Rhinosinusitis in Patients with History of Sino-Nasal Surgery
The FDA has approved Dupixent (dupilumab) for the treatment of allergic fungal rhinosinusitis (AFRS) in adult and pediatric patients aged 6 years and older with a history of sino-nasal surgery. This approval adds AFRS to the drug's indications, which include atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyps, eosinophilic esophagitis, prurigo nodularis, chronic obstructive pulmonary disease, chronic spontaneous urticaria, and bullous pemphigoid. Clinically, this provides a targeted biologic option for patients with AFRS, a condition characterized by type 2 inflammation, potentially addressing unmet needs in this population. The approval is based on its mechanism as an interleukin-4 receptor alpha antagonist, though specific trial data for AFRS efficacy and safety are not detailed in the label. It is administered via subcutaneous injection, with dosing varying by age and weight, and includes limitations such as not being indicated for acute bronchospasm relief in certain conditions.
＋ Clinical Details (Mechanism · Dosing · Trial Data · Warnings)
DUPIXENT is an interleukin-4 receptor alpha antagonist.
DUPIXENT is indicated for the treatment of adult and pediatric patients aged 6 years and older with allergic fungal rhinosinusitis (AFRS) who have a history of sino-nasal surgery. It is also indicated for: adult and pediatric patients aged 6 months and older with moderate-to-severe atopic dermatitis (AD) whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable, with or without topical corticosteroids; as an add-on maintenance treatment of adult and pediatric patients aged 6 years and older with moderate-to-severe asthma characterized by an eosinophilic phenotype or with oral corticosteroid dependent asthma; as an add-on maintenance treatment in adult and pediatric patients aged 12 years and older with inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP); for the treatment of adult and pediatric patients aged 1 year and older, weighing at least 15 kg, with eosinophilic esophagitis (EoE); for the treatment of adult patients with prurigo nodularis (PN); as an add-on maintenance treatment of adult patients with inadequately controlled chronic obstructive pulmonary disease (COPD) and an eosinophilic phenotype; for the treatment of adult and pediatric patients aged 12 years and older with chronic spontaneous urticaria (CSU) who remain symptomatic despite H1 antihistamine treatment; and for the treatment of adult patients with bullous pemphigoid (BP). Limitations of Use: Not for the relief of acute bronchospasm or status asthmaticus in asthma, not for the relief of acute bronchospasm in COPD, and not indicated for other forms of urticaria.
DUPIXENT is administered by subcutaneous injection. For AFRS, dosage in adult and pediatric patients 12 years and older: initial loading dose of 600 mg (two 300 mg injections) followed by 300 mg every 2 weeks (Q2W). For pediatric patients 6 to 11 years of age with AFRS, dosing is based on body weight: 15 to less than 30 kg: 300 mg every 4 weeks (Q4W); ≥30 kg: 200 mg every 2 weeks (Q2W). For other indications, dosing varies by condition, age, and weight, including specific regimens for atopic dermatitis, asthma, and others as detailed in the label.
Trial data not available in label.
Not reported in label.
DUPIXENT is used as a treatment for various inflammatory conditions, including AFRS, where it targets interleukin-4 receptor alpha. It is indicated for patients with specific phenotypes or inadequate control with prior therapies, such as those with AFRS and a history of sino-nasal surgery, and should be used in accordance with its limitations, avoiding use for acute symptoms like bronchospasm.
View Original Abstract ↓
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