{"id":37503,"date":"2019-10-07T15:30:12","date_gmt":"2019-10-07T19:30:12","guid":{"rendered":"https:\/\/sciencebusiness.technewslit.com\/?p=37503"},"modified":"2019-10-07T15:30:12","modified_gmt":"2019-10-07T19:30:12","slug":"peanut-allergy-patch-under-fda-review","status":"publish","type":"post","link":"https:\/\/technewslit.com\/sciencebusiness\/?p=37503","title":{"rendered":"Peanut Allergy Patch Under FDA Review"},"content":{"rendered":"
\"Peanutes<\/a>
(USDA.gov)<\/figcaption><\/figure>\n

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<\/a> in Montrouge, France.<\/p>\n

Allergies to peanuts and other foods result from the body\u2019s immune system misinterpreting certain foods as pathogens, and responding by the release of\u00a0<\/span>histamines<\/a>, chemicals in the body causing the allergy symptoms. In most cases, the symptoms are mild, such as runny nose and itching, but people with\u00a0<\/span>peanut allergies<\/a>\u00a0<\/span>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.\u00a0<\/span>Food Allergy Research and Education<\/a>\u00a0<\/span>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.<\/p>\n

Viaskin Peanut<\/a> is designed to deliver minute quantities of peanut antigens through a patch applied to the skin. The patch is based on the company\u2019s\u00a0Viaskin technology<\/a> that sprays electrically charged proteins \u2014 in this case, peanut antigens \u2014 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\u2019s outer layers.<\/p>\n

In the skin\u2019s outer layers are immune system cells known as\u00a0Langerhans cells<\/a>\u00a0that 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.<\/p>\n

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.<\/p>\n

DBV Technologies says Viaskin Peanut has been tested in two late-stage clinical trials, and six mid- and early-stage trials. Science & Enterprise<\/a> 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.<\/p>\n

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.<\/p>\n

“We know children and their families are seeking a safe and effective treatment that may fit into their daily lives,” says Daniel Tass\u00e9, CEO of DBV Technologies in a company statement<\/a>. “We look forward to continuing to work with the FDA to potentially bring Viaskin Peanut to patients in the second half of 2020.”<\/p>\n

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