Q4 2025 Recap: Allergy News and Updates

The final quarter of 2025 delivered key developments in allergy and immunology, spanning hereditary angioedema (HAE), food allergies, and allergic fungal rhinosinusitis. The US Food & Drug Administration (FDA) approved oral berotralstat, expanding treatment options for pediatric HAE. Phase 3 studies demonstrated rapid-acting HAE therapies, enhanced desensitization protocols in peanut-allergic children, and encouraging outcomes for allergic fungal rhinosinusitis.

In this recap, we spotlighted 8 allergy news stories published between October through December.

FDA Expands HAE Pediatric Treatment Options

FDA Approves Oral Berotralstat for Children Aged 2 – 11 Years with HAE

The FDA approved berotralstat (ORLADEYO) oral pellets for children aged 2 to 11 years with HAE, BioCryst announced on December 12, 2025. Interim APeX-P trial data in 29 pediatric patients showed early and sustained reductions in monthly attack rates. Berotralstat reached peak plasma concentrations at a median of 3.9 hours and demonstrated a safety profile consistent with adult studies.

Phase 3 Highlights: Advances in Allergy Therapies

VIASKIN Peanut Patch Effective in Peanut-Allergic Children Aged 4–7 Years

The phase 3 VITESSE trial showed the VIASKIN Peanut patch significantly improved desensitization in peanut-allergic children aged 4 to 7 years, DBV Technologies announced December 17, 2025. After 12 months, 46.6% of treated children met responder criteria vs 14.8% with placebo, a 31.8% difference (P <.001). Responders increased tolerated peanut protein doses, with no treatment-related serious adverse events and high compliance.

Related: Over 70% of Toddlers Tolerate 3 to 4 Peanut Kernels 3 Years After Peanut Patch

Pharvaris’ Deucrictibant Provides Rapid Relief for HAE in Phase 3 RAPIDe-3 Trial

Pharvaris reported positive phase 3 RAPIDe-3 results showing oral deucrictibant rapidly relieved HAE attacks. In 134 patients aged ≥ 12 years, deucrictibant achieved symptom onset in 1.28 hours vs > 12 hours with placebo and complete resolution in 11.95 hours. Most attacks resolved with a single 20-mg dose, with no treatment-related serious adverse events reported.

Dupilumab Shows Promise for Allergic Fungal Rhinosinusitis in Phase 3 Trial, With Amber Luong, MD, PhD

Phase 3 LIBERTY AIMS data showed dupilumab significantly improved outcomes in allergic fungal rhinosinusitis, a challenging CRSwNP subtype. In 62 patients, dupilumab reduced sinus opacification by 50% vs 9.8% with placebo at 52 weeks and markedly improved nasal polyps and congestion. Treatment lowered the risk of systemic corticosteroid use or surgery by 92%, with a safety profile consistent with prior studies.

The FDA accepted a supplemental Biologics License Application (sBLA) for the priority review of dupilumab for AFRS, with a target action date of February 28, 2026.

Benralizumab Reduces HES Flare in Phase 3 Trial, With Princess Ogbogu, MD

Phase 3 NATRON data showed benralizumab significantly reduced flares in patients with hypereosinophilic syndrome. The randomized, placebo-controlled trial in patients aged ≥ 12 years demonstrated a longer time to first flare, lower annualized flare rates, and reduced hematologic relapse. Benralizumab also improved fatigue scores by week 4, with a safety profile consistent with prior studies targeting the IL-5 receptor.

Trends on HAE, Multi-Allergen OIT, Peanut Allergy Rates

A New Era in Food Allergy Treatment: The Push Toward Multi-Allergen Immunotherapy

Research in 2025 highlighted momentum toward multi-allergen food allergy therapies, led by FDA-approved omalizumab (Xolair), which raises reaction thresholds and improves quality of life in multi-allergic patients. Food allergy prevalence has risen 50% since the 1990s, partly due to delayed allergen introduction. New data on oral and sublingual immunotherapy, including investigational multi-allergen OIT, signal progress toward safer, broader protection beyond single-allergen treatment.

Rare Disease, Rapid Progress: FDA's HAE Approvals in 2025 Signal Changing Course

Before berotralstat, the FDA approved 3 new HAE therapies in 2025—garadacimab-gxii (Andembry), sebetralstat (Ekterly), and donidalorsen (Dawnzera)—signaling rapid progress in this rare disease. These approvals expanded preventive and on-demand options with novel mechanisms, dosing, and administration routes. Experts emphasized that broader treatment choice enables more personalized care and highlighted ongoing unmet needs, particularly for pediatric patients.

Peanut Allergy Rates Plummet 10 Years After AAP Early Introduction Guidelines

A decade after the AAP recommended early peanut introduction, real-world data show a significant decline in peanut allergy rates—27% after 2015 guidelines and 43% after the 2017 addendum. An analysis of > 85,000 children also showed a one-third drop in overall IgE-mediated food allergies. Experts note uneven guideline adoption, emphasizing continued efforts to expand early allergen introduction and further reduce food allergy prevalence across multiple allergens.