DBV Technologies (DBV.PA) shares rise 3.4% on FDA BLA filing for Viaskin Peanut patch ages 4-7
DBV submitted a biologics license application to the FDA for its Viaskin Peanut patch for children aged four to seven. Portzamparc said the milestone follows a failed 2020 application for the 4-11 age group and that the redesigned patch and stronger clinical data support the new submission; DBV requested priority review after breakthrough therapy designation.
S. FDA for its Viaskin Peanut patch in children aged 4 to 7. Portzamparc said the filing was an important milestone for DBV after an earlier unsuccessful application for the 4 to 11 age group in 2020, and said the latest clinical data were stronger because the study met its statistical significance criterion, unlike the first attempt. The broker also said DBV redesigned the patch to make it less likely to fall off accidentally, which it said should help reassure regulators.
The peanut allergy treatment has breakthrough therapy designation, and DBV has requested priority review. S. from children aged 4 to 7 in 2027. 3% year to date.