The Food and Drug Administration agreed to review a skin patch for peanut allergy on an expedited basis following positive results of recent clinical trials, the company said Thursday.
DBV Technologies said that the FDA granted its Viaskin patch “breakthrough therapy designation” for the treatment of peanut allergy in children. The company said it is the first to receive this special designation in the area of food allergy.
The designation means that the FDA will work closely with the company to speed the development and review of Viaskin.
In February, at the annual meeting of the American Academy of Allergy, Asthma and Immunology in Houston, DBV announced that the Viaskin patch had induced tolerance to the equivalent of four peanuts in about half of the patients wearing a 250-microgram skin patch for a year.
Based on those results, the company said that the breakthrough therapy designation was granted, “emphasizing the need to provide a safe pharmaceutical treatment for patients suffering from life threatening food allergies.”
The company is getting ready to launch another clinical trial of Viaskin, called a Phase III trial. The results of Phase III trials ultimately determine whether a product is approved for sale.
Viaskin is also being studied for milk allergy. Viaskin is a form of epicutaneous immunotherapy (EPIT), where patients receive small doses of food protein through their skin.