FDA Approves Dupilumab for Allergic Fungal Rhinosinusitis in Patients 6 Years and Older

The FDA granted approval to dupilumab (Dupixent) as the first and only medication specifically indicated for allergic fungal rhinosinusitis (AFRS) in adult and pediatric patients 6 years and older, according to a news release.¹

“AFRS is a disease that can leave both children and adults with inflamed nasal passages, nasal polyps, and thick mucus causing constant nasal congestion,” Kenneth Mendez, president and CEO of the Asthma and Allergy Foundation of America, said in the news release. “Some patients can also experience more serious complications like deterioration of bone around the sinuses and facial deformities.”

The decision, which followed a priority review, marks a significant shift in the management of a disease that has historically been characterized by high rates of postoperative recurrence and a reliance on systemic corticosteroids. For pharmacists, this approval introduces a targeted biologic option for a patient population that often struggles with a severe, uncontrolled form of chronic rhinosinusitis.¹

READ MORE: Tezepelumab Enhances Sleep and Physical Activity for Patients with Severe Asthma

AFRS is a noninvasive subtype of chronic rhinosinusitis with nasal polyps (CRSwNP) driven by a complex interplay between environmental fungi and a dysfunctional type-2 immune response.^2,3 The condition primarily affects immunocompetent, atopic individuals, often appearing at a younger age than other forms of CRSwNP and more frequently in warm, humid climates. Patients typically present with significant nasal airway obstruction, nasal polyps, and the production of a "peanut butter-like" eosinophilic mucin that is thick, tenacious, and varies in color from tan to black.^2-4

Until this approval, the cornerstone of AFRS management was meticulous functional endoscopic sinus surgery to remove the fungal-laden mucin, followed by aggressive medical therapy.^2-4 However, surgery is not curative, and patients with AFRS face higher revision rates—approximately 28.7%—compared with other CRSwNP patients.

Pharmacological options have been largely limited to corticosteroids, which carry significant long-term risks such as hypertension, osteoporosis, and glucose intolerance. Although providers have explored adjuncts like systemic antifungals, immunotherapy, and off-label compounded topical steroid irrigations, evidence for their effectiveness has remained limited or of low quality.^2,3

“Before Dupixent, people living with AFRS had to rely on treatments that left them potentially vulnerable to regrowth of nasal polyps and thick mucus that could rob them of their sense of smell,” Alyssa Johnsen, MD, PhD, global therapeutic area head of immunology development at Sanofi, said in the news release.¹ “As the first medicine approved specifically for AFRS, Dupixent has been proven to lessen multiple signs and symptoms of disease, help break the cycle of recurrence, and reduce the risk for subsequent surgeries and corticosteroids by 92%.”

The FDA approval of dupilumab was supported by the LIBERTY-AFRS-AIMS (NCT04684524) phase 3 study, which demonstrated that the biologic significantly reduced multiple signs and symptoms of the disease.

In the 52-week trial, patients treated with dupilumab saw a 50% improvement in sinus opacification scores as measured by CT scans, compared with just 10% in the placebo group. Secondary end points were equally robust, showing a 92% reduction in the risk of requiring systemic corticosteroids or additional surgery.

Furthermore, patients reported an 81% improvement in nasal congestion and a significant restoration of their sense of smell. The drug also addressed more serious complications of the disease, such as bone deterioration around the sinuses, which can lead to facial deformities.¹

As a fully human monoclonal antibody, dupilumab works by inhibiting the signaling of IL-4 and IL-13 pathways, which are central drivers of type-2 inflammation. The safety profile observed in the AFRS trial was consistent with its known profile in CRSwNP, with common adverse reactions including injection site reactions, conjunctivitis, and arthralgia.

Pharmacists should note that dosing is age- and weight-based. For adults, the standard dose is 300 mg every 2 weeks. For pediatric patients, the frequency varies from every 2 weeks to every 4 weeks, depending on whether the child weighs more or less than 30 kg.¹

By targeting the underlying molecular drivers of the disease, rather than merely addressing the symptoms, dupilumab offers a new standard of care that may finally break the cycle of recurrence for patients with allergic fungal rhinosinusitis. Although other biologics like omalizumab and mepolizumab have shown promise in smaller case series or for patients with comorbid asthma, dupilumab is now the first to have a dedicated indication for this specific patient population.^1,3

“As the first treatment specifically approved for AFRS, Dupixent offers the potential for relief to adults and children 6 years and older struggling with potentially debilitating symptoms,” concluded AAFA president and CEO Kenneth Mendez.¹

READ MORE: Allergy Resource Center

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REFERENCES

1. Press Release: Sanofi and Regeneron’s Dupixent approved in the US as the first and only medicine for allergic fungal rhinosinusitis. News Release. Sanofi. February 24, 2026. Accessed February 24, 2026. https://www.sanofi.com/en/media-room/press-releases/2026/2026-02-24-14-30-00-3243732

2. Chua AJ, Jafar A, Luong AU. Update on allergic fungal rhinosinusitis. Ann Allergy Asthma Immunol. 2023;131(3):300-306. https://doi.org/10.1016/j.anai.2023.02.018

3. Luong AU, Chua A, Alim BM, et al. Allergic fungal rhinosinusitis: the role and expectations of biologics. JACI: In Practice. 2022;10(12):3156-3162. https://doi.org/10.1016/j.jaip.2022.08.021

4. Chaaban MR. Allergic fungal sinusitis: practice essentials, history of the procedure, problem. Medscape. July 29, 2024. Accessed February 24, 2026. https://emedicine.medscape.com/article/834401-overview?form=fpf