EU Greenlights ARS Pharma’s Game-Changing Nasal Spray Alternative To EpiPen

ARS Pharmaceuticals (SPRY.O) announced on Friday that the European Medicines Agency (EMA) has recommended approval for EURneffy, their needle-free nasal spray for allergic reactions. EURneffy serves as an alternative to epinephrine auto-injectors like EpiPen, used by those at risk of anaphylaxis. Last year, the U.S. FDA declined to approve EURneffy, despite an advisory panel's recommendation, citing the need for a repeat-dose study comparing it to injected products.

In February, the company reported that repeat doses of the drug demonstrated a pharmacokinetic and pharmacodynamic profile that was equal to or better than that of the epinephrine injection. Pharmacokinetics measures how the body processes the drug, while pharmacodynamics assesses the drug's effects on the body. The FDA will re-evaluate the nasal spray and is expected to reach a decision on its approval by October 2. William Blair analyst Tim Lugo noted that the EU's positive recommendation is a promising sign for FDA approval. Patient advocacy groups are likely to use the potential EU approval to urge the FDA to approve the nasal spray before the decision date.