Allergy Month in Review: June 2025

In this month’s allergy review, several key advances indicate treatment progress. The US Food and Drug Administration (FDA) accepted the new drug application (NDA) for Anaphylm, a needle-free epinephrine film, and approved garadacimab-gxii (ANDEMBRY) for hereditary angioedema (HAE) prevention. LYR-210, a six-month nasal implant, showed strong phase 3 results for chronic rhinosinusitis (CRS).

A meta-analysis confirmed the safety of biologics like omalizumab for IgE-mediated food allergies. Finally, new data support the “two-hit” hypothesis: early allergic sensitization combined with respiratory infections may impair lung function into adulthood. This month in review features the top 5 allergy news stories in June.

FDA Allergy Updates with Anaphylm NDA and Garadacimab Approval for HAE

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 epinephrine film designed to treat severe allergic reactions, including anaphylaxis. If approved, it would be the first orally delivered epinephrine option in the US, with a PDUFA action date set for January 31, 2026.

Anaphylm dissolves quickly, is portable, and has shown rapid symptom relief in both adult and pediatric trials with no serious adverse events. Experts believe this device-free option could transform anaphylaxis care by addressing key barriers to epinephrine use: fear of injection and inconvenient storage.

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

The FDA has approved garadacimab-gxii (ANDEMBRY), the first HAE treatment targeting factor XIIa, for patients aged ≥ 12 years. Delivered monthly via a fast, citrate-free subcutaneous autoinjector, the monoclonal antibody offers long-term prevention of HAE attacks.

In the phase 3 VANGUARD trial, the drug reduced attacks by ≥ 99% compared to placebo, with 62% of patients remaining attack-free. Common adverse events included nasopharyngitis and abdominal pain. Long-term data support its safety and efficacy.

LYR-210 Nasal Implant Succeeds in Phase 3 for CRS

LYR-210 Nasal Implant for CRS Brings Symptom Relief in Phase 3 ENLIGHTEN 2

The phase 3 ENLIGHTEN 2 trial showed that LYR-210, a bioabsorbable nasal implant delivering 6 months of continuous mometasone furoate, significantly improved CRS symptoms in patients without nasal polyps. By week 24, patients experienced relief in nasal obstruction, discharge, and facial pain, along with over a 20-point improvement in SNOT-22 scores, exceeding the threshold for clinical significance.

The implant was well-tolerated, with no serious adverse events. CT scans and secondary endpoints supported its benefit, and fewer LYR-210 patients required sinus surgery. Results mark a promising advance for patients with CRS unresponsive to existing therapies.

New Research on Biologics and Lung Impact in Allergy

Biologic Treatments Safe to Recommend for IgE-Mediated Food Allergy, Study Suggests

A new meta-analysis suggests biologic therapies like omalizumab are safe and effective for treating IgE-mediated food allergies. Reviewing 13 randomized controlled trials involving more than 1,000 patients, investigators found that biologics, used alone or with oral immunotherapy (OIT), significantly increased food tolerance and reduced allergic reactions without raising the risk of severe side effects.

Omalizumab, the most studied biologic, helped patients tolerate allergens like peanuts and cow’s milk. While results support the use of biologics in food allergy management, investigators highlighted the need for more long-term data, standardization, and cost-effectiveness analyses to fully guide clinical care.

Childhood Sensitization Plus Respiratory Infections Impair Lung Function by 25

A new study supports the “two-hit” hypothesis, showing that early allergic sensitization combined with respiratory infections in childhood can impair lung function into adulthood, up to age 25 years. The team followed participants from the Melbourne Atopy Cohort and found that sensitized children with frequent infections showed reduced lung function, while infections in non-sensitized children appeared to be protective against lower lung function.

The findings suggest that early-life sensitization makes lungs more vulnerable to damage from infections, while those without sensitization may benefit from immune maturation. The study underscores the importance of preventing respiratory infections in sensitized children to help preserve long-term lung health.