(USDA.gov)
7 Oct. 2019. A device to build a tolerance of peanuts in children with a peanut allergy, worn like a patch on the skin, is under review by the Food and Drug Administration. Viaskin Peanut, the brand name for the device, is made by DBV Technologies in Montrouge, France.
Allergies to peanuts and other foods result from the body’s immune system misinterpreting certain foods as pathogens, and responding by the release of histamines, chemicals in the body causing the allergy symptoms. In most cases, the symptoms are mild, such as runny nose and itching, but people with peanut allergies face a real and elevated risk of anaphylaxis, a life-threatening condition constricting airways, swelling the throat, and causing a sharp drop in blood pressure. Food Allergy Research and Education says some 32 million people in the U.S. including 5.6 million children, have a food allergy, with growing numbers of people reporting an allergy.
Viaskin Peanut is designed to deliver minute quantities of peanut antigens through a patch applied to the skin. The patch is based on the company’s Viaskin technology that sprays electrically charged proteins — in this case, peanut antigens — in a liquid solution that dries and attaches to the back of the patch. The patch forms a condensation layer with the skin, hydrating and dissolving the antigens that penetrate the skin’s outer layers.
In the skin’s outer layers are immune system cells known as Langerhans cells that transport the antigens directly to lymph nodes and T-cells, where they initiate an immune response for training the immune system to tolerate peanut antigens. By transporting antigens through Langerhans cells, says DBV Technologies, the antigens bypass the blood stream, thus avoiding a system-wide immune response.
The company says FDA on Friday accepted the company’s review application as a treatment for children age 4 to 11 years, with a target action date of 5 Aug. 2020. FDA previously designated Viaskin Peanut a breakthrough therapy and qualified the device for a fast-track review. The company submitted its application on 6 Aug. 2019, following its withdrawal of an earlier application in December 2018.
DBV Technologies says Viaskin Peanut has been tested in two late-stage clinical trials, and six mid- and early-stage trials. Science & Enterprise reported on one of the mid-stage clinical studies, showing after a year, nearly half of both the high-dose (48%) and low-dose (46%) patch recipients, age 4 to 25, were able to consume the 10-fold increase in peanut protein. Among participants receiving a placebo patch, only 12 percent were able to tolerate that volume of peanut protein.
The treatments showed more success among younger children, age 4 to 11, than adolescents and young adults age 12 and over. Adherence to the treatments was high, with nearly all participants continuing the treatments for one year. Some 80 percent of respondents receiving the low or high dose patch noted mild or patch-site reactions, with no adverse effects reported.
“We know children and their families are seeking a safe and effective treatment that may fit into their daily lives,” says Daniel Tassé, CEO of DBV Technologies in a company statement. “We look forward to continuing to work with the FDA to potentially bring Viaskin Peanut to patients in the second half of 2020.”
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