DBV Technologies, the French biotech company developing a skin patch to treat peanut allergy, has had their request for market approval turned down by the FDA. This comes as a significant setback for the company which is said to have been working towards getting the patch onto the market by the end of this year.
Viaskin™ Peanut is being developed as a non-invasive, once-daily skin patch to treat peanut allergies in children aged 4 to 11 years. In their response to DBV , the FDA noted concerns about the adhesion data supplied and indicated the need for modifications to the patch. Once modified, additional clinical data would be required.
The FDA’s response comes shortly after DBV reported the latest Journal of Allergy and Clinical Immunology.
DBV have previously said they hope to use the skin patch technology in other applications to deliver biologically active compounds to the immune system through intact skin. The technology is enclosed in an adhesive patch and works by creating a ‘condensation chamber’ that makes the skin wet and allows the compound to pass through the skin in small amounts. This allows the person being treated to gradually become resistant to it over time.
Despite the need to undertake a significant amount of additional work, DBV has said they continue to believe in the potential of Viaskin Peanut™ and will collaborate fully with the FDA regarding the outstanding issues.