SBTX Silverback Therapeutics Inc

By Sabela Ojea

Silverback Therapeutics Inc. said Friday that the U.S. Food and Drug Administration has accepted for review its new drug application for Neffy, an emergency nasal spray to treat allergic reactions.

The clinical-stage biopharmaceutical company said Neffy was developed by ARS Pharmaceuticals Inc., the company it acquired in July for the potential commercialization of the treatment.

The FDA has assigned a prescription drug user fee act target action date that is expected in mid-2023, Silverback Therapeutics said.

Neffy has the potential to become the first needle-free medicine to treat allergic reaction, Silverback Therapeutics said.

The only FDA-approved medication for these reactions are epinephrine autoinjectors, but some patients delay this emergency because of being afraid of needles, amid other reasons, the company said.

Type 1 emergency allergic reactions are potentially life-threatening events that can occur within minutes after being exposed to an allergen that need further treatment options, Silverback Therapeutics said. There are between 25 million to 40 million people in the U.S. who experience this type of allergic reactions, the company said.

Write to Sabela Ojea at sabela.ojea@wsj.com; @sabelaojeaguix

(END) Dow Jones Newswires

October 21, 2022 08:21 ET (12:21 GMT)

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