Q3 2025 Recap: Allergy News and Updates

As Q3 closes, HCPLive revisits key advances in allergy and immunology, highlighting emerging therapies and practical clinical strategies. Over the past months, clinicians have gained insight into intranasal epinephrine for anaphylaxis, the expanding role of brief cognitive behavioral therapy (bCBT) for food allergy–related anxiety, and the integration of motivational interviewing to improve patient adherence and outcomes.

This article includes regulatory updates, including the US Food & Drug Administration (FDA) approving donidalorsen and sebetralstat for hereditary angioedema (HAE) attacks, as well as an in-depth interview with Marcus Shaker, MD, detailing how allergist-immunologists can apply brief CBT and risk-reframing strategies in routine practice. The discussion emphasizes evidence-based approaches, patient-centered care, and scalable interventions for managing psychosocial impacts of food allergies.

Q3 2025 Regulatory Updates in Allergy

FDA Approves Donidalorsen to Prevent Hereditary Angioedema Attacks

The FDA has approved donidalorsen (DAWNZERA), an RNA-targeted therapy, to prevent HAE attacks in adults and children aged ≥ 12 years. Clinical trials, including OASIS-HAE, OASISplus, and a phase 2 OLE study, showed donidalorsen significantly reduced monthly HAE attacks by up to 81%, with sustained efficacy over several years. The therapy, administered via subcutaneous injection every 4 or 8 weeks, also improved patient quality of life and was well-tolerated, with mostly mild adverse events.

Related: Donidalorsen Shows Promise Reducing HAE Attacks Ahead of August PDUFA

Sebetralstat FDA-Approved as First Oral, On-Demand for Hereditary Angioedema

The FDA has approved sebetralstat (Ekterly), the first oral, on-demand therapy for acute HAE attacks in patients aged ≥ 12 years. Developed by KalVista Pharmaceuticals, sebetralstat is a plasma kallikrein inhibitor that enables rapid, self-administered treatment, giving patients greater independence and aligning with clinical guidelines. Phase 3 KONFIDENT and KONFIDENT-S trials showed symptom relief beginning within hours and complete resolution within 24 hours for most attacks, with a favorable safety profile. By offering a non-injectable option, sebetralstat represents a major advance in HAE care.

Updated Advisory for Penicillin Allergy

Cephalexin Recommended for Dermatologic Surgery with Penicillin Allergy

The American Society for Dermatologic Surgery now recommends cephalexin as the first-line prophylactic antibiotic for patients with penicillin allergy undergoing dermatologic surgery. Evidence shows that while roughly 10% of U.S. patients report penicillin allergy, 90% are not truly IgE-mediated allergic, and 80% lose sensitivity after 10 years. Cephalexin, a first-generation cephalosporin, has very low cross-reactivity with penicillin, particularly when R1 side chains differ, and demonstrates superior efficacy and safety compared with alternatives.

Q3 Phase 3 Data in Allergy

First in Class Cat, Birch Allergen Blockers Succeed in Phase 3 Trials

Regeneron’s first-in-class allergen-blocking antibodies have met primary endpoints in phase 3 trials for cat and birch allergies, showing rapid and significant symptom relief. In the cat allergy trial, a FelD1-targeting antibody combination reduced ocular itch by 52% and conjunctival redness by 39%, with even greater improvements in patients specifically sensitive to FelD1. In the birch allergy trial, BetV1-targeting antibodies reduced itch by 51% and redness by 46%. Both therapies were well-tolerated with no serious adverse events.

Allergy Expert Perspectives You May Have Missed

Brief CBT Eases Food Allergy Anxiety, With Marcus Shaker, MD

Marcus Shaker, MD, highlights the role of brief cognitive behavioral therapy (bCBT) and motivational interviewing in managing food allergy–related anxiety. In an HCPLive interview, he explained that patients often experience both generalized and food-specific anxiety, exacerbated by misconceptions about risk. Shaker outlined practical strategies allergist-immunologists can use, including risk reframing, proximity challenges, and brief in-office CBT interventions, to help patients build confidence and reduce maladaptive behaviors.

One Year Later: How Intranasal Epinephrine Is Changing Emergency Allergy Treatment

One year after FDA approval, neffy, the first intranasal epinephrine for anaphylaxis, is demonstrating practical utility in clinical settings. Interviews with Matthew Greenhawt, MD, MBA, MSc, Brian Schroer, MD, Colleen Kraft, MD, MBA, Ryan Haumschild, PharmD, MS, MBA, and Thomas Casale, MD, provide insights on real-world use, patient selection, and adherence. Clinicians note its utility in patients with needle aversion or pediatric populations (≥4 years, 15–<30 kg), while ongoing evaluation addresses prescription fulfillment, insurance coverage, and integration into emergency protocols. Early experience suggests intranasal epinephrine is a feasible alternative to autoinjectors, with potential to improve timely administration and patient outcomes in anaphylaxis management.