Back in October 2019, DBV Technologies submitted their Biologics License Application (BLA) to the Food and Drug Administration to market their Viaskin® Peanut “patch” immunotherapy for children ages 4-11. Then, in February of this year, the company announced they had secured a meeting with the FDA’s Allergenic Products Advisory Committee (APAC) for May 15 to discuss the application with a target date of August 5, 2020, for possible FDA approval of the therapy.
In a press release yesterday, the company announced that a number of questions were surfaced by the FDA regarding the long-term efficacy and impact of patch-site adhesion of Viaskin Peanut. As a result, the APAC meeting has been postponed indefinitely. The meeting is generally the last step before the FDA decides whether to approve a drug contingent upon APAC’s recommendation.
DBV will draw upon information from its clinical trials of Viaskin Peanut to answer the FDA’s concerns, but there is as yet no amended timeline for the APAC meeting and target date for possible approval. The company warned the FDA’s target date for their decision could be delayed.
Said Daniel Tassé, CEO of DBV Technologies:
We appreciate the ongoing dialogue with the FDA and look forward to further discussions in the coming weeks. We believe in the clinical benefit observed in Viaskin Peanut clinical trials to date and will continue to work closely with the FDA to potentially bring Viaskin Peanut to children as quickly as possible.