DBV Technologies seeks FDA approval for peanut allergy patch

DBV Technologies has submitted a biologics license application (BLA) to the FDA for VIASKIN, a peanut allergy patch intended for children aged four through seven. The company has also requested a priority review for the treatment. The application is supported by Phase 3 trial data involving 654 children across the United States, Canada, Britain, Europe, and Australia. In these trials, 46.6 percent of treated children met response criteria compared to 14.8 percent in the placebo group.

Separately, researchers are advancing microneedle technology for peanut allergy immunotherapy. A first-in-human Phase 1 clinical trial, led by Children’s Healthcare of Atlanta and Emory University School of Medicine, is evaluating a microneedle stamp developed by Moonlight Therapeutics, Inc. This device is designed to deliver controlled doses of peanut protein through the skin. The current study focuses on the safety and tolerability of the device before moving toward testing its ability to produce clinical desensitization.