BLA for Novel Peanut Allergy Treatment Submitted to FDA
Viaskin Peanut, an epicutaneous immunotherapy, delivers small amounts of peanut protein through a wearable patch
The Biologics License Application (BLA) for Viaskin Peanut (DBV Technologies) has been submitted to the Food and Drug Administration (FDA) for the treatment of peanut allergy in children 4-11 years old.
Viaskin Peanut, an epicutaneous immunotherapy (EPIT), delivers small amounts of peanut protein through a wearable patch to induce desensitization. The BLA included data from two Phase 3 trials, PEPITES and REALISE, as well as long-term data from an open-label Phase 2 program.
In the PEPITES study, the safety and efficacy of Viaskin Peanut 250µg peanut protein to induce desensitization to peanut in peanut-allergic children 4 through 11 years of age after a 12-month treatment was evaluated. Results showed that 35.3% of study patients had a statistically significant response vs 13.6% of patients in the placebo arm. For patients with a baseline peanut protein eliciting dose (ED) ≤10mg, a responder was defined as a patient with a peanut protein ED ≥300mg of peanut protein after 12 months of treatment. For patients with a baseline ED >10mg, a responder was defined as a patient with a peanut protein ED ≥1000mg of peanut protein after 12 months of treatment.
Data from the REALISE study further demonstrated a favorable safety and tolerability profile. "We believe that the safety and efficacy data generated in our clinical trials support our mission to potentially offer EPIT, a proprietary desensitization treatment, to peanut-allergic children in an easy and convenient manner for families,” said Dr Hugh Sampson, Chief Scientific Officer of DBV Technologies and Kurt Hirschhorn Professor of Pediatrics at the Icahn School of Medicine at Mount Sinai.
For more information visit dbv-technologies.com.