FDA Puts a Partial Clinical Hold on Viaskin Peanut Patch

The US Food and Drug Administration (FDA) has put a partial clinical hold on the phase 3 VITESSE (Viaskin Peanut Immunotherapy Trial to Evaluate Safety, Simplicity and Efficacy) clinical trial testing the efficacy and safety of epicutaneous immunotherapy with the modified Viaskin Peanut 250 µg patch in peanut-allergic children ages 4-7 years.

In the partial clinical hold letter, the FDA request changes to certain elements of the VITESSE protocol to order to support a future Biologics License Application (BLA) submission by DBV Technologies, including the statistical analysis of adhesion, minimum daily wear time, and technical alignments in methods of categorizing data to meet the study objectives.

According to a press release by DBV, the company has not yet begun to screen or recruit patients for the trial.

DBV is expected to provide additional updates after they consult with the FDA.

"We are grateful for the FDA's additional feedback reflecting careful attention to DBV's VITESSE study," said Daniel Tassé, Chief Executive Officer of DBV Technologies, in a statement. "We are pleased that the comments to the protocol are specific, clear and arrived prior to enrollment. We look forward to upcoming discussions with key FDA personnel."