By Christy Santosh

LONDON: ARS Pharmaceuticals said on Friday that European Medicines Agency (EMA) has recommended Approval Its needle-free emergency treatment, EuroNEFFor allergic reactions.

nasal spray EURneffy is seen as an alternative to EPI pen and other autoinjectors that are filled EpinephrineIt is a life-saving medication, used by people at risk of anaphylaxis and other allergic reactions.

Last year, the U.S. Food and Drug Administration refused to approve the spray, a decision that went against the recommendation of its advisory panel, as the agency sought to study the treatment’s dosing regimens against a rival injectable product.

In February, the company said that the pharmacokinetic and pharmacodynamic profile of the drug upon repeated dosing appeared to be similar to or superior to that of epinephrine injection.

Pharmacokinetics is the measure of how the body interacts with a drug, and pharmacodynamics is the measure of how a drug affects the body.

FDA The government will re-review the nasal spray and decide on its approval by October 2.

William Blair analyst Tim Lugo said the EU recommendation bodes well for FDA approval. Patient advocacy groups will (likely) use the EU approval to pressure the FDA to approve the nasal spray before the decision date.

The European Commission, which usually follows the EMA’s recommendation, is expected to make a decision on EURneffy in the third quarter of 2024, Ars said.

Shares of the California-based company rose nearly 2% in morning trade. (Reporting by Christy Santosh; Editing by Nivedita Bhattacharjee and Shailesh Kuber)