June 28 (Reuters) - ARS Pharmaceuticals ( SPRY ) 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.