DBV Tech Gets Requested Feedback from FDA on Comfort Safety Studies

By Stephen Nakrosis

DBV Technologies said it received requested feedback from the U.S. Food and Drug Administration for a pair of supplemental safety studies looking at its ViaSkin peanut allergy treatment.

The Characterization of the Optimal Management of Food Allergy Relief and Treatment, or Comfort, studies, will look at DBV's ViaSkin patches in children age 1 to 3 years old and in children age 4 to 7 years, the company said.

DBV said it has received FDA feedback clarifying design elements for both the Comfort Toddlers and Comfort Children supplemental safety studies. Both studies will have harmonized language guiding how the product will be used in the trials, and will "seek to enroll populations that are closely aligned with their respective Phase 3 efficacy studies, as is feasible," DBV said.

The company will implement FDA feedback, it said, adding that a submission of the final Comfort Toddlers protocol design will go to the FDA in the coming weeks. DBV also said it expects the first subject will be enrolled in the first quarter of next year.

The initiation of Comfort Children is expected after the start of Comfort Toddlers, DBV said.

Write to Stephen Nakrosis at [e-mail]

(END) Dow Jones Newswires

October 31, 2023 18:33 ET (22:33 GMT)

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