5 Allergy Headlines You Missed in August 2025

In this month’s allergy review, several developments mark progress in the field. The US Food and Drug Administration (FDA) approved donidalorsen (DAWNZERA), the first RNA-targeted prophylaxis for hereditary angioedema (HAE). Additionally, the American Society for Dermatologic Surgery issued an advisory recommending cephalexin as the preferred antibiotic for patients who are allergic to penicillin.

This month in review features the top 5 allergy headlines from August 2025.

FDA Approval in the Allergy Field

FDA Approves Donidalorsen to Prevent Hereditary Angioedema Attacks

The FDA has approved donidalorsen (DAWNZERA), the first RNA-targeted therapy to prevent hereditary angioedema (HAE) attacks in patients aged 12 years and older. The approval was supported by data from the phase 3 OASIS-HAE and OASISplus trials, as well as the ongoing phase 2 OLE trial, which demonstrated sustained efficacy, safety, and improved quality of life.

In OASIS-HAE, donidalorsen reduced monthly HAE attacks by 81% versus placebo with every-4-week dosing. Patients switching from other prophylactic therapies experienced further reductions in attack rates, with most preferring donidalorsen. The therapy was well-tolerated, with mild injection site reactions as the most common adverse events.

Updated Advisory in Penicillin Allergy

Cephalexin Recommended for Dermatologic Surgery with Penicillin Allergy

The American Society for Dermatologic Surgery has issued an advisory recommending cephalexin as the first-line prophylactic antibiotic for patients with documented penicillin allergy undergoing dermatologic surgery. Although about 10% of US patients report a penicillin allergy, most do not have a true IgE-mediated reaction, and 80% lose sensitivity within 10 years.

Evidence shows low cross-reactivity between penicillins and cephalosporins, with cephalexin offering superior efficacy and safety compared to alternatives. The advisory reflects updated data showing only about 4% of patients with reported penicillin allergy are hypersensitive to cephalexin, supporting its safe and effective use in this population.

Recent Studies on HAE, Automated Skin Prick Test

Oral Berotralstat Shows Strong Safety, Efficacy in Young Children with HAE

A recent interim analysis from the APeX-P trial found that oral berotralstat is effective and well-tolerated for hereditary angioedema (HAE) prophylaxis in children aged 2–11 years. The study, the largest of its kind in this age group, included 29 patients and showed early and sustained reductions in HAE attack rates over 48 weeks, with median rates dropping to zero per 4-week period.

Adverse events were mostly mild, including nasopharyngitis, upper respiratory infection, and headache, with no grade 3 or 4 reactions or treatment-related discontinuations. These findings highlight berotralstat’s potential as a safe, noninvasive long-term prophylaxis for young children.

Automated Skin Prick Test at 4.5 mm Cut-Off Matches Accuracy of Traditional Method

A recent study found that the Skin Prick Automated Test (SPAT) with a 4.5 mm cut-off provides equivalent accuracy to conventional skin prick testing for detecting birch pollen and house dust mite allergies. Among 75 adults with or without allergic rhinitis, SPAT achieved 96% accuracy compared with 98% for the standard method, with both tests correctly identifying all negative controls. SPAT also showed reduced variability linked to operator technique while maintaining high sensitivity. Investigators concluded that allergists could incorporate SPAT into routine practice as a reliable, standardized alternative for allergy diagnosis without compromising accuracy or safety.

1 Year Since the Approval of Epinephrine Nasal Spray (neffy)

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

One year after FDA approval of intranasal epinephrine (neffy), a panel of experts—including Matthew Greenhawt, MD, MBA, MSc; Brian Schroer, MD; Colleen Kraft, MD, MBA; Ryan Haumschild, PharmD, MS, MBA; and Thomas Casale, MD—reflected on its impact in clinical practice. They discussed real-world adoption, access barriers, and patient selection since neffy became the first needle-free epinephrine option for anaphylaxis.. The clinicians emphasized the importance of ongoing education as additional non-injectable options emerge to expand emergency allergy treatment.