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EU regulator backs approval for ARS Pharma's nasal spray alternative to EpiPen
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EU regulator backs approval for ARS Pharma's nasal spray alternative to EpiPen
Jun 28, 2024 8:49 AM

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.

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