DBV Technologies is withdrawing its marketing application for a peanut allergy therapy following discussions with the Food and Drug Administration, the company said Wednesday.
Based on feedback from regulators, DBV concluded that its submission lacked “sufficient detail regarding data on manufacturing procedures and quality controls.” The company believes it can re-file with the FDA without having to conduct any additional clinical trials, although when that will happen was not made clear.
DBV shares were halted at $14.15 ahead of the announcement.
The company is developing a wearable patch, called Viaskin Peanut, that is intended to build tolerance to peanut protein in kids with severe peanut allergy.
Last year, in a trial on more than 300 children with peanut allergies, about 35 percent of patients responded to Viaskin, but the overall results didn’t beat placebo by enough to meet the study’s primary goal. DBV blamed the failure on a statistical issue and a better-than-expected response in placebo patients.
The FDA did not cite any issues with the Viaskin clinical trial data in its recent meetings with the company, it said.
DBV’s setback could be a boost to Aimmune Therapeutics, which is expected to file a competing peanut allergy treatment with the FDA before the end of the year.
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