DBV Technologies announces FDA alignment on Viaskin Peanut patch program pathway

DBV Technologies (DBVT) announced the successful outcome of recent written and oral communication with the FDA that provides a regulatory pathway for the Viaskin Peanut patch program in toddlers 1-3-years-old. The FDA has formalized guidance on an accelerated approval for the Viaskin Peanut patch in toddlers 1-3-years-old. DBV and FDA have agreed on the key design elements for a post-marketing confirmatory study.