The United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) has granted approval for a new, lower dose of ALK-Abelló’s EURneffy, a groundbreaking adrenaline nasal spray designed to treat anaphylaxis. This pivotal decision significantly expands access to a needle-free treatment option for younger children at risk of severe allergic reactions, marking a substantial advancement in paediatric emergency care. The approval of the 1mg dose means that children aged 4 years and older, weighing between 15kg and 30kg, are now eligible for this innovative delivery system. This move builds upon the prior authorisation of the 2mg EURneffy product, which was cleared for adults and children aged 10 and above, weighing 30kg or more, in July 2025.
Expanding Access to Life-Saving Treatment
Anaphylaxis, a life-threatening allergic reaction, can occur rapidly and unexpectedly in response to a variety of triggers, including common foods, insect stings, and certain medications. In Europe, an estimated 761 out of every 100,000 children experience anaphylaxis annually, with food allergies accounting for over two-thirds of these cases. The urgency of anaphylaxis necessitates immediate intervention, and adrenaline remains the gold standard treatment for mitigating its severe and potentially fatal effects. Historically, the primary method of delivering adrenaline in emergency situations has been through injectable auto-injectors.
The introduction of EURneffy represents a significant departure from traditional needle-based delivery. This needle-free approach aims to address several barriers that have historically hindered timely and effective anaphylaxis management, particularly among children. Fear of needles, known as trypanophobia, can lead to significant anxiety and hesitation in young patients and their caregivers, potentially delaying crucial treatment. Furthermore, even with accessible auto-injectors, incorrect administration or the inability to administer the injection due to the patient’s distress can compromise its effectiveness.
A Timeline of Innovation and Expansion
The journey of EURneffy, and its US counterpart Neffy, has been marked by strategic development and regulatory milestones. The nasal spray was initially developed by ARS Pharmaceuticals. In November 2025, ALK-Abelló secured European and Canadian rights to EURneffy through an upfront deal valued at $145 million, demonstrating strong confidence in the product’s potential. ARS Pharmaceuticals retained the marketing rights for the United States, where the nasal spray is marketed as Neffy.
The regulatory pathway in the US also saw progress, with the Food and Drug Administration (FDA) widening the paediatric label for Neffy in March 2026. This expansion in the US market mirrored the growing recognition of the nasal spray’s utility across different age groups. The subsequent MHRA approval of the 1mg dose in the UK for younger children further solidifies this trend, indicating a global shift towards more accessible and patient-friendly anaphylaxis treatments.
Addressing the Limitations of Injectable Devices
While injectable adrenaline auto-injectors, such as Mylan’s EpiPen, have been a mainstay in anaphylaxis management for years, their limitations have become increasingly apparent. Beyond the psychological barrier of needles, concerns have also been raised about the cost and accessibility of these devices, which have been subject to significant pricing controversies over the past decade. Analysts have highlighted that the nasal spray formulation of EURneffy offers a simpler, more intuitive, and potentially more cost-effective alternative, thereby improving adherence and timely intervention in critical moments.
Flora Beiche-Scholz, ALK’s Executive Vice President for Commercial Operations Europe, emphasized the transformative potential of the new approval. "For decades, children at risk of anaphylaxis have been limited to injectable adrenaline – yet fear of needles, hesitancy to act and incorrect administration mean adrenaline is too often not carried or used in time," she stated. "EURneffy 1mg aims to address these barriers, offering a needle-free adrenaline solution with the potential to transform the lives of those living with, or caring for, children with severe allergies." This sentiment underscores the direct impact the MHRA’s decision will have on families and healthcare providers.
Market Potential and Future Outlook
The commercial prospects for EURneffy and Neffy appear robust, with significant market potential projected. According to ARS Pharmaceuticals, Neffy generated $20.3 million in full-year 2025 sales. Looking ahead, industry analysis from GlobalData predicts that the drug will achieve $1 billion in global net sales by 2032. This impressive forecast is likely driven by the expanding indications, the growing awareness of anaphylaxis risks, and the inherent advantages of a needle-free delivery system, particularly in the paediatric population. The approval of the lower dose in the UK is expected to be a significant contributor to this upward trajectory, opening up a substantial new patient cohort.
Broader Implications for Public Health and Allergy Management
The MHRA’s approval of the 1mg EURneffy dose has far-reaching implications for public health and the management of severe allergies in children. By providing a needle-free option, the UK regulatory body is not only enhancing patient comfort but also potentially improving treatment adherence and reducing the burden on caregivers. This development could lead to:
- Increased Preparedness: Parents and guardians may feel more confident carrying and administering the nasal spray, leading to better preparedness in case of an allergic reaction.
- Reduced Healthcare System Strain: Earlier and more effective treatment at home could potentially reduce the number of emergency room visits and hospital admissions related to anaphylaxis.
- Enhanced Quality of Life: For children who experience significant anxiety around needles, this new option offers a less distressing pathway to managing their allergy, contributing to a better overall quality of life.
- Innovation Catalyst: The success of EURneffy may spur further innovation in the field of anaphylaxis treatment, encouraging the development of other needle-free delivery methods or alternative therapeutic approaches.
The regulatory landscape for anaphylaxis treatments has been evolving, and the approval of EURneffy’s lower dose in the UK represents a significant step forward. It highlights a growing understanding of the need for diverse and patient-centric treatment modalities, especially for vulnerable populations like children. As the prevalence of allergies continues to be a global health concern, innovations like EURneffy are crucial in ensuring that individuals have access to the most effective and accessible treatments available. The MHRA’s decision is a testament to the ongoing efforts to improve emergency care and mitigate the risks associated with severe allergic reactions for the youngest members of society.
