Q2 2025 Recap: 5 Allergy Updates to Know

In Q2 2025, allergy-related updates included notable US Food and Drug Administration (FDA) actions and clinical guidance. The FDA approved garadacimab-gxii (ANDEMBRY), the first factor XIIa-targeting treatment for HAE prevention in patients aged ≥ 12 years.

The FDA also accepted BioCryst’s new drug application (NDA) for berotralstat oral granules, which could become the first oral prophylactic therapy for hereditary angioedema (HAE) in children under 12 years. Cetirizine and levocetirizine labels will now include warnings about severe itching after discontinuation following long-term use. Furthermore, new clinical guidelines outlined when to consider sinus surgery for chronic rhinosinusitis, offering 11 evidence-based recommendations to guide diagnosis, treatment, and surgical decision-making.

FDA Updates in Allergy

FDA Accepts Epinephrine (Anaphylm) Sublingual Film NDA for Type 1 Allergic Reactions

The FDA has accepted Aquestive Therapeutics’ NDA for Anaphylm, a needle-free sublingual film delivering epinephrine for severe allergic reactions, including anaphylaxis. If approved, it would be the first oral epinephrine option in the US.

Designed for ease of use and portability, Anaphylm dissolves quickly without water and could address key barriers to epinephrine use—needle fear and bulky auto-injectors. Clinical trials in adults and children showed rapid symptom relief, strong safety, and comparable pharmacokinetics to current treatments. The FDA has set a PDUFA action date of January 31, 2026, and may hold an Advisory Committee meeting.

FDA Approves Factor XIIa-Targeting Garadacimab-gxii (ANDEMBRY) for HAE Attacks

The FDA has approved garadacimab-gxii (ANDEMBRY), the first treatment targeting factor XIIa to prevent HAE attacks in patients aged ≥ 12 years. Delivered monthly via a citrate-free autoinjector, it offers a convenient alternative to more frequent injections.

In the phase 3 VANGUARD trial, garadacimab-gxii reduced HAE attacks by > 99% compared to placebo, with 62% of patients remaining attack-free. Common side effects included nasopharyngitis and abdominal pain. Long-term data support its safety and efficacy.

FDA Warns About Rare, Severe Itching After Stopping Cetirizine or Levocetirizine

The FDA has issued a warning about rare but severe pruritus (itching) after stopping long-term use of cetirizine (Zyrtec) or levocetirizine (Xyzal), even in patients who did not previously have itching. The warning will be added to both prescription and over-the-counter labels. Most of the 209 reported global cases occurred in the US, often after months or years of daily use.

Symptoms typically begin within days of stopping and may improve if the medication is restarted. Healthcare providers are urged to inform patients of this risk when prescribing or recommending these antihistamines for allergic conditions.

FDA Accepts BioCryst’s NDA for Berotralstat Oral Granules in Children With HAE

The FDA has accepted BioCryst’s New Drug Application for berotralstat (ORLADEYO) oral granules to prevent HAE attacks in children aged 2 to 11 years, granting it priority review with a target action date of September 12, 2025. If approved, it would become the first oral prophylactic therapy for this age group.

The NDA is supported by positive interim data from the APeX-P trial, showing early and sustained attack reduction. Berotralstat is already approved for patients aged ≥ 12 years. The treatment was well tolerated in children, with a safety profile consistent with previous findings.

New CRS Guidelines

New Guidelines Outline When to Consider Sinus Surgery for Chronic Rhinosinusitis

New guidelines from the American Academy of Otolaryngology-Head and Neck Surgery Foundation outline when to consider sinus surgery for chronic rhinosinusitis. Released on May 27, 2025, the 11 evidence-based recommendations emphasize confirming diagnosis, avoiding unnecessary antibiotics, and considering surgery when medical therapy is ineffective. Surgery is especially beneficial for patients with nasal polyps, fungal infections, or worsening conditions like asthma.

The guidelines also stress CT imaging for planning, realistic patient expectations, and proper follow-up. Developed by an expert panel, the guidelines aim to improve patient outcomes and support shared decision-making throughout surgical care.