ARS Pharmaceuticals Gets CHMP Backing for Epinephrine Nasal Spray

Dow Jones06-28 18:50

By Colin Kellaher

ARS Pharmaceuticals has moved a step closer to winning European approval of its proposed epinephrine nasal spray for the emergency treatment of severe allergic reaction.

ARS on Friday said the European Medicines Agency's Committee for Medicinal Products for Human Use has recommended approval of the drug, which the San Diego company plans to market as "EURneffy."

The European Commission, which generally follows CHMP's advice, will now review the recommendation, with a decision expected in the third quarter.

ARS said a green light would make EURneffy the first and only approved needle-free adrenaline option in Europe for the emergency treatment of allergic reactions.

ARS said the CHMP's positive opinion is based on the same data package the company submitted to the U.S. Food and Drug Administration in April in its second bid for FDA approval of the drug.

The FDA, which last year rejected ARS's initial application, has set a target action date of Oct. 2 for the drug, which ARS plans to market as "neffy" in the U.S.

Write to Colin Kellaher at colin.kellaher@wsj.com

(END) Dow Jones Newswires

June 28, 2024 06:50 ET (10:50 GMT)

Copyright (c) 2024 Dow Jones & Company, Inc.

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