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FDA approved Dupixent (dupilumab) for Allergic Fungal Rhinosinusitis in Patients with History of Sino-Nasal SurgeryFDA approved Dupixent for treating allergic fungal sinus infections in patients who have had sinus surgery

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Key Takeaway
Consider Dupixent for AFRS in patients aged 6+ with sino-nasal surgery history, per FDA approval.

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)
Mechanism of Action

DUPIXENT is an interleukin-4 receptor alpha antagonist.

Indication & Patient Population

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.

Dosing & Administration

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.

Key Clinical Trial Data

Trial data not available in label.

Warnings & Contraindications

Not reported in label.

Place in Therapy

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.

The U.S. Food and Drug Administration (FDA) has approved the drug Dupixent for treating allergic fungal sinus infections in adults and children aged 6 and older who have had sinus surgery. This condition involves inflammation in the sinuses caused by an allergic reaction to fungus. Dupixent is already approved for several other conditions including eczema, asthma, and certain sinus problems with nasal polyps.

This approval means that patients with allergic fungal sinus infections who have had sinus surgery now have another treatment option available. Dupixent works by targeting specific inflammation pathways in the body. It is given as an injection under the skin, with the dose depending on the patient's age and weight.

It's important to understand that this approval adds allergic fungal sinus infections to the list of conditions Dupixent can treat. The drug is not meant for immediate relief of breathing problems or asthma attacks. As with any medication, patients should talk with their doctor about whether this treatment might be right for their specific situation.

One honest caveat is that while this approval is based on the drug's known mechanism of action, the specific trial results for treating allergic fungal sinus infections are not detailed in the official labeling. This doesn't mean the drug isn't effective, but it does mean patients should have thorough conversations with their healthcare providers about all available information.

What this means for you:
Patients with allergic fungal sinus infections who have had surgery now have another treatment option to discuss with their doctor.

Study Details

Study typeFda approval
PublishedMar 2017
View Original Abstract ↓
1 INDICATIONS AND USAGE DUPIXENT is an interleukin-4 receptor alpha antagonist indicated: Atopic Dermatitis for the treatment of adult and pediatric patients aged 6 months and older with moderate-to-severe AD whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. DUPIXENT can be used with or without topical corticosteroids. ( 1.1 ) Asthma 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. ( 1.2 ) Limitations of Use: Not for the relief of acute bronchospasm or status asthmaticus. ( 1.2 ) Chronic Rhinosinusitis with Nasal Polyps 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). ( 1.3 ) Eosinophilic Esophagitis for the treatment of adult and pediatric patients aged 1 year and older, weighing at least 15 kg, with eosinophilic esophagitis (EoE). ( 1.4 ) Prurigo Nodularis for the treatment of adult patients with prurigo nodularis (PN). ( 1.5 ) Chronic Obstructive Pulmonary Disease as an add-on maintenance treatment of adult patients with inadequately controlled chronic obstructive pulmonary disease (COPD) and an eosinophilic phenotype. ( 1.6 ) Limitations of Use: Not for the relief of acute bronchospasm. ( 1.6 ) Chronic Spontaneous Urticaria 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. ( 1.7 ) Limitations of Use: Not indicated for other forms of urticaria. ( 1.7 ) Bullous Pemphigoid for the treatment of adult patients with bullous pemphigoid (BP). ( 1.8 ) Allergic Fungal Rhinosinusitis 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. ( 1.9 ) 1.1 Atopic Dermatitis DUPIXENT is indicated for the treatment of 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. DUPIXENT can be used with or without topical corticosteroids. 1.2 Asthma DUPIXENT is indicated 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. Limitations of Use DUPIXENT is not indicated for the relief of acute bronchospasm or status asthmaticus. 1.3 Chronic Rhinosinusitis with Nasal Polyps DUPIXENT is indicated 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). 1.4 Eosinophilic Esophagitis DUPIXENT is indicated for the treatment of adult and pediatric patients aged 1 year and older, weighing at least 15 kg, with eosinophilic esophagitis (EoE). 1.5 Prurigo Nodularis DUPIXENT is indicated for the treatment of adult patients with prurigo nodularis (PN). 1.6 Chronic Obstructive Pulmonary Disease DUPIXENT is indicated as an add-on maintenance treatment of adult patients with inadequately controlled chronic obstructive pulmonary disease (COPD) and an eosinophilic phenotype. Limitations of Use DUPIXENT is not indicated for the relief of acute bronchospasm. 1.7 Chronic Spontaneous Urticaria DUPIXENT is indicated 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. Limitations of Use: DUPIXENT is not indicated for treatment of other forms of urticaria. 1.8 Bullous Pemphigoid DUPIXENT is indicated for the treatment of adult patients with bullous pemphigoid (BP). 1.9 Allergic Fungal Rhinosinusitis 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.
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