In developing an adhesive patch treatment, DBV Technologies, believed they found an effective and safe method to provide help to those suffering from peanut allergies. The Food and Drug Administration didn’t agree. The FDA has decided not to approve, at least for now, DBV Technologies’ Viaskin Peanut, a skin patch allergy desensitization treatment. The FDA’s concern appears to be around the issue of adhesion to the skin and its possible impact on treatment. While the FDA’s decision was met with disappointment within the food allergy community and DBV, there continues to be hope that the needed changes can be made, that the FDA will be able to approve and that a new treatment for peanut allergy sufferers will be available.
By: Gwen Smith
August 4, 2020
The FDA says it won’t approve DBV Technologies’ Viaskin Peanut, the novel skin patch allergy desensitization treatment, at least not in its current form.
In announcing the drug regulator’s decision, DBV said in a press release that the FDA raised concerns about Viaskin patch’s adhesion to the skin and the impact of that on treatment. To address the concerns, DBV says the FDA calls for patch modifications, followed by “a new human factor study.”
The company’s leadership vows to comply with the FDA’s requests and move forward. “We are very disappointed in the FDA’s response, but continue to believe in the potential of Viaskin Peanut,” Daniel Tassé, CEO of DBV, said in the August 4 release.
DBV says the FDA also requested further clinical data on chemistry and manufacturing. No safety concerns were raised related to the therapy.