The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Eurneffy (epinephrine), marking it as the first nasal spray for the emergency treatment of allergic reactions, specifically anaphylaxis.

Allergy Prevalence and Anaphylaxis

Allergies are a significant chronic disorder in Europe, affecting 150 million Europeans in 2015, according to the European Academy of Allergy and Clinical Immunology (EAACI). About 20% of those with severe allergic conditions live in constant fear of anaphylactic shock, a potentially fatal reaction that can occur within minutes of exposure to allergens such as food, medications, or insect stings.

Mechanism of Adrenaline

Anaphylaxis is the most severe allergic reaction, and adrenaline (epinephrine) is the primary treatment. Adrenaline binds to adrenergic receptors, reducing blood vessel dilation and permeability caused by histamine, and relaxes smooth muscles in the lungs. This improves blood flow and breathing during an anaphylactic reaction.

Challenges with Current Treatments

While epinephrine autoinjectors are effective, their use can be hindered by needle fear, portability issues, and reluctance among non-medical individuals to administer injections. Eurneffy's nasal spray formulation addresses these concerns, offering a needle-free alternative that is rapidly absorbed through the nasal mucosa.

Clinical Evaluation

Due to ethical and practical constraints, controlled clinical trials on Eurneffy's effectiveness in severe allergic reactions were not feasible. However, adrenaline's use in treating severe allergies is well-documented. Eurneffy's efficacy and safety were assessed in 537 healthy individuals aged 19 to 55 across 14 clinical studies, comparing its effects to intramuscularly injected adrenaline. Results showed that the nasally-administered adrenaline had comparable pharmacodynamics and pharmacokinetics to the injected form.

Adverse Events and Risk Minimization

No significant adverse events were reported in the studies. Common side effects included nausea, headache, throat irritation, dizziness, nasal discomfort, and a runny nose. The CHMP has recommended additional risk minimization measures, such as training videos and digital educational materials for patients, carers, and healthcare professionals. A training demonstration device will also be provided to ensure proper use.

Next Steps

The CHMP's positive opinion is a critical step towards Eurneffy's market availability. The opinion will be forwarded to the European Commission for a decision on EU-wide marketing authorization. Post-authorization, individual Member States will make decisions regarding pricing and reimbursement, considering the medicine's role within their national health systems.

Highlights

The EMA's CHMP has recommended the approval of Eurneffy, the first nasal spray for anaphylaxis treatment. Allergies affect 150 million Europeans, with 20% at risk of anaphylactic shock. Eurneffy provides a needle-free alternative to epinephrine autoinjectors, showing comparable efficacy and safety in clinical trials. The CHMP advises additional risk minimization measures, and the European Commission's approval is pending.