6 Allergy Headlines You Missed in July 2025

Several key studies and recommendations signaled meaningful shifts in clinical practice for the allergy field. From the US Food and Drug Administration (FDA) approval of sebetralstat (Ekterly) as the first oral, on-demand treatment for hereditary angioedema (HAE) to new data supporting donidalorsen’s efficacy in patients switching from other prophylactics, therapeutic options continue to expand.

This July Month in Review also explores a study replacing skin testing with direct challenge in children and a clinician-backed approach to easing food allergy anxiety.

FDA Updates in Allergy

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

The FDA has approved sebetralstat (Ekterly), the first oral, on-demand treatment for acute HAE attacks in patients aged ≥ 12 years. Developed by KalVista Pharmaceuticals, the plasma kallikrein inhibitor offers a more convenient alternative to injectables, allowing earlier intervention and increased patient independence.

Approval was supported by phase 3 KONFIDENT trial data, which showed rapid symptom relief and effective resolution in adolescents. No serious safety concerns emerged.

Latest Findings in HAE

Donidalorsen Shows Promise Reducing HAE Attacks Ahead of August PDUFA

Donidalorsen demonstrated strong efficacy in reducing HAE attacks in the phase 3 OASISplus switch study, ahead of its anticipated August 2025 FDA decision. Patients switching from other prophylactic therapies—lanadelumab, C1-esterase inhibitor, or berotralstat—saw a 62% further reduction in mean monthly attack rates, with no increase in breakthrough attacks. Most patients preferred donidalorsen due to improved disease control, easier administration, and fewer injection site reactions.

Lanadelumab Cuts Monthly HAE Attack Rates in Real-World 3-Year Study

A real-world, 3-year study found that lanadelumab significantly reduced monthly HAE attacks—from 54% of patients experiencing ≥1 attack monthly before treatment to just 9.8% post-treatment. Quality of life also improved, with 88.2% of patients reporting good or excellent QoL at the time of the survey. Attack severity declined, with no severe attacks reported at 36 months.

Other Recent Discoveries in Allergy

Direct Challenge Safely Replaces Skin Testing for Pediatric Penicillin Allergy

A study found that direct drug provocation testing (DPT) can safely replace penicillin skin testing in children with mild, non-severe reactions. Among 75 pediatric participants from Türkiye with suspected penicillin allergy, only 4 tested positive on DPT, all with mild cutaneous symptoms. No patients had positive specific IgE to penicillin, and most tolerated antibiotics afterward.

The findings suggest DPT may reduce unnecessary skin testing in cases of mild urticaria or exanthema, easing discomfort for children. While promising, investigators emphasized the need for larger, multicenter studies to confirm safety and guide future practice, especially in avoiding overuse of alternative antibiotics.

NICE Recommends Betula Verrucosa for Severe Birch Tree Allergy

The National Institute for Health and Care Excellence (NICE) has recommended betula verrucosa (Itulazax 12 SQ-Bet) for treating moderate-to-severe birch tree pollen allergies in individuals aged ≥ 5 years. Unlike symptom-masking treatments, this daily sublingual immunotherapy retrains the immune system over 3 years to tolerate pollen.

A phase 3 trial showed a 33% reduction in symptoms and 47% less medication use compared to placebo. Patients in England with confirmed birch pollen allergy will gain access within 3 months of NICE’s final guideline. Although generally well-tolerated, treatment may cause mild, temporary allergic reactions in the early stages.

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

Brief cognitive behavioral therapy (CBT) and motivational interviewing may help ease food allergy anxiety by shifting patients' focus from fear to confidence, according to Marcus Shaker, MD, from Dartmouth Geisel School of Medicine. Speaking with HCPLive, Shaker explained that patients often overestimate the risk of severe allergic reactions, which contributes to psychosocial impairment.

Brief CBT can reframe these misperceptions using relatable analogies and “curious questions,” even within a standard clinic visit. Strategies such as proximity and threshold challenges help reframe risk, supporting patient well-being and making integrated behavioral care more accessible across settings.