By Christy Santhosh
(Reuters) -ARS Pharmaceuticals said on Friday the European Medicines Agency (EMA) has recommended the approval of its needle-free emergency treatment, EURneffy, for allergic reactions.
The nasal spray EURneffy is seen as an alternative to EpiPen and other autoinjectors that are filled with epinephrine, a life-saving drug used by people at risk of anaphylaxis and other allergic reactions.
Last year the U.S. Food and Drug Administration had declined to approve the spray, a decision that was in contrast to the recommendation of its advisory panel, as the agency sought a repeat-dose study of the treatment versus a rival injected product.
In February the company said repeat doses of the drug showed a pharmacokinetic and pharmodynamic profile greater than or similar to the epinephrine injection.
Pharmacokinetics is a measure of how the body interacts with the drug and pharmacodynamics is the drug's effect on the body.
The FDA will review the nasal spray again and is expected to decide on its approval by Oct. 2.
William Blair analyst Tim Lugo said the EU recommendation bodes well for a FDA approval. Patient advocacy groups will use (a potential) EU approval to pressure the FDA to approve the nasal spray ahead of the decision date.
ARS said the European Commission, which usually follows the EMA's recommendation, is expected to decide on EURneffy in the third quarter of 2024.
Shares of the California-based company were up about 2% in morning trading.
(Reporting by Christy Santhosh; Editing by Nivedita Bhattacharjee and Shailesh Kuber)