DBV Technologies SA has refiled an application with the U.S. Food and Drug Administration seeking approval for its peanut allergy therapy Viaskin Peanut.
The company's biologics license application is supported by data from eight clinical trials. It aims to get the regulator's authorization to treat peanut-allergic children aged 4 to 11 years.
Previously, the Montrouge, France-based company had withdrawn its application for Viaskin Peanut in December 2018. This occurred after discussions with the FDA, which concluded that the application lacked sufficient data regarding manufacturing procedures and quality controls.
Viaskin Peanut is a patch applied to the back, providing desensitization to the peanut allergen. It received breakthrough and fast-track designation from the regulatory agency in 2015 and 2012, respectively.
The therapy is competing with Aimmune Therapeutics Inc.'s AR101 to get to market. The FDA is reviewing Aimmune's application for the therapy to treat children and adolescents with a peanut allergy. A decision is expected by January 2020.
In July, U.S. drug pricing watchdog the Institute for Clinical and Economic Review concluded that clinical data does not demonstrate whether long-term benefits of AR101 and Viaskin Peanut outweigh their short-term risks. ICER noted that desensitization, as measured by an oral food challenge, may be promising. But data was insufficient to demonstrate a superior net health benefit of either AR101 or Viaskin Peanut compared to strict peanut avoidance.