Overview

• At the SIAAIC congress in Milan, specialists said the product has reached the final stage of AIFA review, with Italian availability expected in 2026, a development seen as significant given roughly 10,000 anaphylaxis cases and 60–70 deaths annually in Italy.
• The intranasal formulation was approved by the FDA and EMA in August 2024 and is already available in Germany.
• Clinical data presented by SIAAIC include a study in Journal of Allergy & Clinical Immunology: In Practice showing symptom reduction within 5 minutes and median complete resolution around 16 minutes in children and adolescents.
• Real‑world experience with autoinjectors shows major barriers: 25–60% of patients refuse injection, administration is often delayed up to 9 minutes, 20–70% use the device incorrectly, and 24–50% fail to purchase or replace it, with half not carrying adrenaline consistently.
• Practical advantages highlighted include needle‑free use and about 30 months of shelf life without special storage, while current limits restrict use to patients weighing at least 30 kg and call for further safety evaluation in elderly and cardiac populations.