DBV Tech Gets Requested Feedback from FDA on Comfort Safety Studies
31 Ottobre 2023 - 11:48PM
Dow Jones News
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 stephen.nakrosis@wsj.com
(END) Dow Jones Newswires
October 31, 2023 18:33 ET (22:33 GMT)
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