DBV Technologies SA voluntarily withdrew its application seeking U.S. Food and Drug Administration approval for peanut allergy therapy Viaskin Peanut after discussions with the regulator.
The Montrouge, France-based company was seeking the agency's approval for Viaskin Peanut for treating peanut allergy in children four to 11 years old. The biologics license application was supported by data from seven clinical trials, including two phase 3 trials.
DBV Technologies concluded that the application lacks sufficient data regarding manufacturing procedures and quality controls after feedback from the U.S. FDA, the company said in a news release.
The company said it is working with the FDA to resubmit the application and added that no further clinical studies are needed to support the filing.
Viaskin Peanut previously received fast track and breakthrough designations from the U.S. regulator in 2012 and 2015, respectively.