Dupixent Approved in the US for Allergic Fungal Rhinosinusitis
Sanofi and Regeneron announce the FDA approval of Dupixent (dupilumab) for treating allergic fungal rhinosinusitis in adults and children aged 6 years and older. This marks the first and only medication specifically approved for this chronic type 2 inflammatory condition.
FDA Approval Details
The FDA has approved Dupixent 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. The review was granted priority status by the FDA, reserved for drugs that represent significant improvements in the treatment of serious conditions. This approval expands the approved indications for Dupixent in sino-nasal diseases to include AFRS as well as chronic rhinosinusitis with nasal polyps. AFRS is a chronic type 2 inflammatory disease caused by intense allergic hypersensitivity to fungi, primarily affecting individuals in warm and humid climates. It leads to inflammation of the nasal passages, nasal polyps, nasal congestion, loss of smell, and thick mucus. Some patients experience severe complications such as bone deterioration around the sinuses and facial deformities. The current treatment relies on surgery and prolonged administration of systemic steroids, but recurrences remain frequent.
Clinical Trial Insights
The approval is based on the phase 3 LIBERTY-AFRS-AIMS study conducted on 62 adults and children aged 6 years and older with AFRS. Patients received Dupixent according to age and weight, administered every two or four weeks, or a placebo. Dupixent is a subcutaneous injection intended to be used under medical supervision and can be administered in a clinic or at home after proper training. In children under 12 years of age, the injection must be performed by a caregiver if done at home. Dupixent is a fully human monoclonal antibody that inhibits the signaling pathways of interleukin-4 (IL-4) and interleukin-13 (IL-13) and is not an immunosuppressant. Additional submissions are planned with other regulatory authorities worldwide. Sanofi and Regeneron are launching the DUPIXENT MyWay® program to help American patients access the medication. Dupixent has already received regulatory approvals in over 60 countries for one or more indications, and more than 1.4 million patients are being treated globally.
