DBV Technologies (DBVT) said late Wednesday the US Food and Drug Administration has formalized guidance on an accelerated approval for the Viaskin Peanut patch in peanut-allergic children aged between one and three years.
The parties have agreed on the key design elements for a post-marketing confirmatory study, including study size and wear time collection methodology and analysis, the company said.
"In the recent written communication, the FDA confirmed the efficacy data from the company's phase 3 EPITOPE study can serve as an intermediate clinical endpoint," DBV said. "The FDA has agreed that the endpoint is reasonably likely to predict clinical benefit and will therefore fulfill the requirement for accelerated approval."
The company said it intends to screen the first subject in Q2 2025. It expects the biologic license application for the Viaskin Peanut patch in the said age group to be submitted for accelerated approval in H2 2026.
DBV shares were up 27% in after-hours activity.
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