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DBV Technologies' application for peanut allergy therapy accepted by US FDA

DBV Technologies SA said the U.S. Food and Drug Administration accepted its application for peanut allergy therapy Viaskin Peanut.

The Montrouge, France-based company resubmitted the application in August after withdrawing a previous application for the allergy therapy based on discussions with the FDA, which noted that the application lacked sufficient data regarding manufacturing procedures and quality controls.

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.

The FDA expects to make a decision on the application by Aug. 5, 2020.

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 accepted Aimmune's application for the drug to treat children and adolescents with a peanut allergy and will make a decision by January 2020.

The U.S. drug pricing watchdog Institute for Clinical and Economic Review released a report in July that said clinical evidence does not demonstrate that long-term benefits of AR101 and Viaskin Peanut outweigh their short-term risks.

ICER also 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.