French biopharmaceutical company DBV Technologies moves closer to bringing its peanut allergy patch to market, receiving Breakthrough Therapy Designation from the U.S. Food and Drug Administration as it prepares to launch its Phase 3 trial.
The circular patch, called Viaskin Peanut, delivers peanut protein directly onto the superficial layers of the skin so that it is slowly administered into the immune system, but does not pass into the bloodstream. By avoiding the bloodstream, the therapy has been shown to significantly reduce the chance of anaphylactic shock from peanut exposure in children across ages. The worst side effects in clinical Phase 2 trials were localized rashes, according to the company.
The patch could prevent anaphylactic shock if someone with a peanut allergy were to accidentally eat something with traces of peanuts, or an amount roughly equivalent to four peanuts, according to a company representative.
“We are truly honored to be the first company to receive this FDA designation in food allergies,” Dr. Pierre-Henri Benhamou, M.D., Chairman and CEO of DBV Technologies said. “This is an historical event for the peanut allergy patients, caretakers and clinicians that have long awaited for a treatment for this severe disease.”
The Breakthrough Therapy designation, which is intended to expedite the development and review of drugs/biological products that target serious or life-threatening conditions, is specifically for the treatment of peanut allergies in children, from toddlers to teenagers. A Breakthrough Therapy drug must show preliminary clinical evidence of a substantial improvement on a clinically significant endpoint over available therapies, or over placebo if there is no available therapy.
While still a couple of years away from commercial development, the therapy has promise for the potentially life-threatening disease, and was granted a Fast Track designation from the FDA in December of 2011.
DBV Technologies is also developing a patch for milk allergies and a treatment for dust mites.
Filed Under: Drug Discovery