In this recap of 7 FDA updates and 2 interview spotlights in allergy from the first half of 2025, we review important advances in allergy care. At the 2025 American Academy of Allergy, Asthma, & Immunology (AAAAI) in San Diego, oral immunotherapy showed promise for peanut allergy in young children, and tezepelumab improved nasal polyp severity in CRSwNP.

US Food and Drug Administration (FDA) activity included the acceptance of Anaphylm’s epinephrine film NDA, the approval of garadacimab-gxii for HAE, and new warnings for cetirizine. Additional approvals expanded access to omalizumab biosimilars, pediatric HAE treatment, and a needle-free option for pediatric anaphylaxis.

2 Allergy Interviews on Phase 2 or 3 Data

Tezepelumab Lowers Nasal Polyp Severity in CRSwNP During Phase 3 WAYPOINT, with Joseph Han, MD

In the phase 3 WAYPOINT trial, tezepelumab significantly reduced nasal polyp severity and nasal congestion in patients with CRSwNP. The treatment lowered the need for surgery by 92% and improved symptoms like loss of smell and quality of life scores, showing early and sustained benefit over 52 weeks.

Oral Immunotherapy Shows Promise for High Threshold Peanut Allergy, with Scott Sicherer, MD

At AAAAI 2025, Scott Sicherer, MD, from Mt. Sinai School of Medicine, presented phase 2 data showing that 100% of children with high-threshold peanut allergy on oral immunotherapy tolerated 9043 mg of peanut, versus 10% in the avoidance group. The study highlights a promising, simple treatment option—using store-bought peanut butter under allergist supervision.

7 FDA Updates in Allergy

FDA Approvals

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

Approval date: June 16, 2025.

The FDA approved garadacimab-gxii (ANDEMBRY), the first treatment targeting factor XIIa to prevent hereditary angioedema (HAE) attacks in patients aged ≥ 12 years. In the VANGUARD trial, it reduced HAE attacks by over 99%. The once-monthly, citrate-free injection offers a convenient, effective option for long-term HAE management with a strong safety profile.

FDA Approves First Interchangeable Biosimilar for Omalizumab

Approval date: March 9, 2025

The FDA approved omalizumab-igec (OMLYCLO) as the first interchangeable biosimilar to Xolair for asthma, CRSwNP, food allergy, and chronic spontaneous urticaria. Phase 3 data confirmed its bioequivalence, safety, and efficacy, offering a more affordable treatment option to expand patient access and reduce healthcare costs.

FDA Approves 1 mg Neffy Nasal Spray for Pediatric Anaphylaxis

Approval date: March 5, 2025

The FDA approved 1 mg neffy epinephrine nasal spray for children aged 4+ weighing 15–30 kg, offering a needle-free alternative for pediatric anaphylaxis. This user-friendly design may reduce hesitation, improve adherence, and enhance emergency treatment outcomes. Availability is expected by May 2025.

FDA Accepts 2 Allergy NDA’s

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

PDFA date: January 31, 2026

The FDA accepted the NDA for Anaphylm, a needle-free epinephrine sublingual film for severe allergic reactions, with a target decision date of January 31, 2026. Clinical data showed rapid symptom relief and no serious adverse events. If approved, Anaphylm could transform anaphylaxis care with its portable, easy-to-use design.

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

PDUFA date: September 12, 2025

The FDA accepted BioCryst’s NDA for berotralstat oral granules to prevent HAE attacks in children aged 2–11 years, granting priority review with a target decision date of September 12, 2025. If approved, it would be the first oral prophylactic therapy for HAE in children under 12 years.

Other Notable Allergy News

Palforzia Now Available in US for Children Aged 1 – 3 Years with Peanut Allergy

Palforzia is now available in the US for children aged 1–3 years with confirmed peanut allergy, addressing a critical unmet need. FDA approval, based on the successful POSEIDON trial, supports early oral immunotherapy to desensitize young children and help prevent peanut allergy progression during immune development.

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

The FDA is adding warnings to cetirizine and levocetirizine labels after identifying rare cases of severe itching (pruritus) upon stopping long-term use. Most of the 209 global cases occurred in the US. Patients should be informed of this risk before starting treatment, especially for chronic use.