The company, focused on solutions for severe allergic reactions was granted the approval last week, on August 22. This marks a signifcant advancement in the treatment of severe allergies across Europe.
Breakthrough approval for EURneffy marks a new era in allergy treatment
It represents a significant advancement in the treatment of severe allergic reactions across Europe.
This impressive development offers a new option for millions of individuals who suffer from severe allergies and anaphylaxis, addressing longstanding challenges associated with traditional needle-based treatments.
A new option for severe allergic reactions
For decades, adrenaline (epinephrine) has been the standard treatment for severe allergic reactions, including anaphylaxis. Traditionally administered through needle injectors, these devices, while effective, pose several challenges. Many patients delay or avoid using needle-based devices due to fear, complexity, or the inconvenience of carrying them. This delay can be life-threatening, as timely administration of adrenaline is crucial in stopping the progression of a severe allergic reaction.
“Adrenaline is the only first-line treatment for allergic reactions, including anaphylaxis, yet there is significant underutilization of adrenaline due to the limitations of current available therapy,” explains Dr Antonella Muraro, professor of food allergy at the University of Padua and lead author of the European Academy of Allergology and Clinical Immunology (EAACI) treatment guidelines for anaphylaxis.
“The approval of EURneffy provides the first needle-free treatment option available in the EU for adults and children (≥30 kg) with severe allergies, many of whom may not carry, or delay use of, an injectable adrenaline product.”
Addressing unmet needs in allergy management
Richard Lowenthal, co-founder, president, and CEO of ARS Pharmaceuticals, highlights the broader impact of this approval.
“This approval marks an important moment for the severe allergy community in the EU, and the first novel adrenaline delivery method in more than three decades,” he says. “EURneffy’s needle-free, smaller form and longer, less temperature-sensitive shelf life may increase the likelihood that patients will both carry and administer adrenaline, which improves the outcome of allergic reactions.”
Lowenthal's insights highlight the innovation behind EURneffy, particularly its significance in overcoming the barriers associated with traditional epinephrine injectors. He notes that approximately half of those prescribed an epinephrine injector do not carry it consistently, and among those who do, many delay or avoid using it during an emergency.
This concern is echoed by Muraro, who believes EURneffy will change the landscape of anaphylaxis treatment in Europe. “It will facilitate getting adrenaline into patients in a timely manner, ending up in a less severe reaction or preventing progression to a life-threatening reaction,” she explains.
Extensive Research and Development
The European Commission's approval was based on a comprehensive review of data from one of the most extensive nasal spray development programs in history. This program involved over 700 study participants and more than 1,200 administrations. The pharmacodynamics and pharmacokinetics of EURneffy were rigorously evaluated across various dosing conditions, including single and repeat dosing, self-administration by
patients, and use in pediatric cases. The trials demonstrated that EURneffy provides adrenaline exposure and pharmacodynamic responses comparable to those of traditional injection products.
“EURneffy was determined by the European Medical Agency to be interchangeable with injection products given it provides the same exposures to adrenaline and even better pharmacodynamic response as approved injection products,” Lowenthal explains.
Muraro adds that the needle-free delivery method of spray aligns well with the latest EAACI guidelines for treating anaphylaxis.
“The guidelines advocate for very prompt administration of adrenaline. With current methods, there are some psychological and social barriers for adrenaline injection that delay use,” she says.
A new standard in anaphylaxis treatment
The importance of EURneffy’s approval extends beyond its needle-free convenience. For those with severe allergies, particularly those living in fear of anaphylactic shock, the spray represents a safer, more accessible option. According to the EAACI, around 20% of people with severe allergic conditions live in constant fear of anaphylaxis - a reaction that can be sudden and fatal without prompt treatment.
Muraro emphasizes the potential impact of EURneffy on patient outcomes. “Patients may develop more confidence in the administration of adrenaline using the spray even when in doubt of a reaction,” she says.
She also highlights that for patients who are not compliant with carrying or using their adrenaline injection products, that this is a very positive option. However, she advises that patients who are already comfortable with their current devices might consider keeping them until more real-world experience with EURneffy is available.
Looking ahead: a landmark achievement
With its approval, EURneffy will soon be available to patients in several EU member states, anticipated by the last quarter of this year (2024). The product benefits from significant data and marketing protection in Europe, ensuring its unique position in the market until at least 2039.
The advent of the spray signals a new era in the management of severe allergic reactions, providing a needle-free alternative that could significantly improve patient outcomes.
Reflecting on the broader implications, Muraro sees this development as a catalyst for future research and development in allergy treatments. “It represents the first step in developing more understanding on the treatment of anaphylactic reactions, and hopefully, this is the beginning of a new generation of user-friendly tools for the administration of adrenaline,” she adds.
ARS says this approval is a landmark achievement in the field of allergy treatment, offering hope to millions of patients who may now have a more user-friendly option to manage their severe allergies. As the first needle-free adrenaline product approved in the EU, EURneffy not only marks a breakthrough in drug delivery but also a significant step forward in patient care.
