A peanut allergy patch being developed by French group DBV Therapeutics has been awarded breakthrough status by the US Food and Drug Administration, marking the first such designation within the food allergy field.
Viaskin Peanut is an electrostatic patch that delivers peanut protein directly onto the superficial layers of the skin, activating the immune system without entering the bloodstream. Crucially, this has been shown to significantly reduce the risk of anaphylaxis in children exposed to peanuts.
Mid-stage clinical data show that Viaskin Peanut improved peanut allergy disease in children as measured by “a clinically significant endpoint”, and that the product has an “excellent safety profile”, according to the firm.
The FDA’s breakthrough designation “highlights the urgent need to find a treatment for this life-threatening disease,” noted DBV’s chairman and chief executive Pierre-Henri Benhamou, also stressing that the firm intends to bring Viaskin Peanut to market “as quickly as possible”.
DBV is currently “actively preparing” the launch of its Phase III trial of Viaskin Peanut in paediatric peanut allergy sufferers, in close coordination with the FDA, it said.