EURneffy Receives EU Approval for Allergy Treatment

EURneffy Approved in the EU for Allergy Treatment

EURneffy represents a significant advancement in the treatment of severe allergic reactions for both adults and children (?30 kg) in the EU. This new delivery method for adrenaline, the first in over 30 years, provides a crucial option for individuals facing the risk of anaphylaxis.

Details on the Approval Process

The European Commission's approval follows a similar nod from the FDA in the United States. The approval was granted based on a thorough review of one of the most comprehensive nasal spray development programs conducted, including studies involving more than 700 participants and over 1,200 administrations.

Significance of Needle-Free Delivery

Dr. Antonella Muraro, MD PhD, a leading expert in food allergy at the University of Padua, highlights the issue of underutilization of adrenaline due to the limitations of existing therapies. According to Dr. Muraro, "Adrenaline is the only first-line treatment for allergic reactions including anaphylaxis, yet significant barriers exist that prevent its effective use." The introduction of EURneffy aims to overcome these obstacles, providing a convenient and effective alternative for those who may not be able to use traditional injectable adrenaline products.

The Impact on Allergy Management

Richard Lowenthal, Co-Founder and CEO of ARS Pharma, expressed the importance of this innovation: "Today’s approval is a landmark moment for the severe allergy community, marking the first novel method of adrenaline delivery in over three decades." The needle-free delivery system of EURneffy is expected to enhance compliance among patients, potentially reducing the incidence of severe allergic reactions.

Evaluation of Efficacy and Safety

Comprehensive evaluations of the pharmacodynamics and pharmacokinetics of 2 mg EURneffy were performed under various dosing conditions. Key focuses included self-administration by patients, dosing in pediatric populations, and effectiveness during conditions that cause nasal congestion. This broad evaluation was essential in ensuring that EURneffy is reliable for patients in real-world scenarios.

Intellectual Property and Market Protection

With an eight-year period of data protection for its development data, EURneffy also enjoys a ten-year marketing protection period, preventing the entry of generics into the EU market for a decade. Moreover, the composition and method patents for EURneffy in Europe are set to last until 2039, ensuring that ARS Pharmaceuticals retains its competitive edge.

Looking Ahead: Availability for Patients

ARS Pharma anticipates making EURneffy available in select EU Member States in the latter part of the year, through a pharmaceutical partner with an established market presence. This anticipated launch aims to ensure that patients can access this life-saving medication with minimal delay.

Understanding Anaphylaxis and Allergy Responses

Type I allergic reactions, including anaphylaxis, are critical and potentially fatal conditions that require immediate medical intervention. Epinephrine remains the only approved treatment in the EU for such emergencies. Traditional adrenaline autoinjectors, although effective, have limitations such as patient reluctance to administer them due to fear of needles and the complexity of the devices, which can delay treatment during crucial moments.

About ARS Pharmaceuticals, Inc.

ARS Pharmaceuticals is a dedicated biopharmaceutical company focused on developing innovative treatments for severe allergic reactions. The firm is commercializing EURneffy in the EU as a groundbreaking intranasal epinephrine product tailored for patients susceptible to life-threatening anaphylaxis.

Frequently Asked Questions

What is EURneffy?

EURneffy is the first needle-free adrenaline nasal spray approved for treating anaphylaxis in the European Union.

How does EURneffy benefit patients?

By offering a needle-free alternative, EURneffy may improve adherence to emergency treatment protocols during allergic reactions.

What was the basis for EURneffy’s approval?

The approval was based on extensive clinical trials involving hundreds of participants, ensuring its efficacy and safety in treating severe allergic reactions.

When will EURneffy be available in the EU?

EURneffy is expected to be available to patients in select EU Member States by the end of 2024.

Who developed EURneffy?

EURneffy was developed by ARS Pharmaceuticals, a company committed to enhancing the safety of patients at risk of severe allergic reactions.

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