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This month in review features 7 allergy headlines in February 2026: FDA's decision on Dupilumab for AFRS, late-breaking data presented at AAAAI, & more.
February 2026 brought several notable developments across allergy and immunology, spanning regulatory decisions, updated clinical guidance, and emerging research presented at the 2026 American Academy of Allergy, Asthma, & Immunology annual meeting in Philadelphia from February 27 to March 2. From the US Food and Drug Administration (FDA) approval of dupilumab for allergic fungal rhinosinusitis to a Complete Response Letter for dibutepinephrine (Anaphylm), the month reflected both progress and ongoing hurdles in therapeutic development.
At the same time, updated guidance for hereditary angioedema (HAE) and anaphylaxis highlighted the field’s continued shift toward earlier, patient-directed treatment. Additionally, late-breaking data explored genetic predictors of severe drug reactions and new treatment pathways for peanut allergy.
Here, HCPLive highlighted the top 7 allergy headlines clinicians may have missed in February.
Sanofi and Regeneron Pharmaceuticals announced on February 24, 2026, that the FDA approved dupilumab (Dupixent) for allergic fungal rhinosinusitis (AFRS) in patients ≥6 years with prior surgery. Phase 3 LIBERTY-AFRS-AIMS showed improved Lund-Mackay CT scores and reduced corticosteroid or surgery risk by 92%.
The FDA issued a Complete Response Letter (CRL) to Aquestive Therapeutics for dibutepinephrine (Anaphylm) sublingual film for type 1 allergic reactions, citing human factors issues with pouch opening and film placement. Aquestive plans packaging modifications, new human factors and pharmacokinetic studies, and resubmission by Q3 2026.
Related: Anaphylm Remains Promising for Anaphylaxis Despite FDA CRL, With David Golden, MD
New pediatric HAE guidance recommends sebetralstat (Ekterly) as first-line on-demand therapy for attacks in adolescents aged ≥ 12 years. Backed by phase 3 KONFIDENT data, the oral kallikrein inhibitor, developed by KalVista Pharmaceuticals, supports rapid self-administration and early treatment.
Related: HAE Guidelines Reinforce Early On-Demand Treatment, With Mauro Cancian, MD, PhD
Allergy experts David Golden (Johns Hopkins) and Jay Lieberman (University of Tennessee Health Science Center), moderated by Brian Schroer of the Cleveland Clinic, discussed updated anaphylaxis guidance from the AAAAI and American College of Allergy, Asthma & Immunology (ACAAI), emphasizing early epinephrine use and reduced reliance on corticosteroids or antihistamines in acute management.
An international panel led by Timothy E. Dribin of Cincinnati Children’s Hospital Medical Center developed consensus guidance on epinephrine use for allergic reactions. Experts agreed epinephrine is warranted for multi-organ involvement or severe respiratory/cardiovascular symptoms, but found uncertainty for moderate isolated skin or mucosal reactions in community anaphylaxis management.
At AAAAI, Matthew Krantz, MD, of Vanderbilt University Medical Center, reported prospective case-control data linking HLA-A*32:01 to lamotrigine-induced Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS). Carriers had an approximately 12-fold greater risk, suggesting potential value for causality assessment and future pharmacogenomic screening.
At AAAAI, Scott H. Sicherer, MD, director of the Elliot and Roslyn Jaffe Food Allergy Institute and a pediatric allergy professor at the Icahn School of Medicine at Mount Sinai, discussed the NIH-sponsored CAFETERIA trial showing that gradual home dosing with peanut butter enabled children with high-threshold peanut allergy to tolerate 9 g peanut protein, with many achieving sustained unresponsiveness. The study shows promise of a new treatment pathway beyond strict avoidance for selected patients.
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