The U.S. Food and Drug Administration accepted for review the Biologics License Application (BLA) for DBV Technologies’ investigational Viaskin Peanut immunotherapy for the treatment of peanut-allergic children ages 4 to 11 years.
A U.S. Food and Drug Administration advisory panel recommended approving the first therapy for peanut allergies, which affect over 1.6 million children in the United States, despite raising concerns about the risk of severe allergic reactions Palforzia poses to young patients.
After an eight month delay, France-based DBV Technologies announced the resubmission of a Biologics License Application to the U.S. FDA for the non-invasive allergy patch Viaskin Peanut.
Aimmune Therapeutics announced that the Brisbane, Calif.-based company’s Phase III European clinical trial of AR101 for the treatment of peanut allergy met the primary efficacy endpoint.
About 400 U.S. Food and Drug Administration staffers returned to their posts from furlough, including some food inspectors and support professionals, Commissioner Scott Gottlieb said in a tweet.
Aimmune Therapeutics announced the publication of the company’s successful Phase III PALISADE clinical trial of AR101 to desensitize patients with peanut allergies. The research was published in the New England Journal of Medicine.
Nestle’s health science arm will pay $98 million to raise its stake in Aimmune Therapeutics in preparation of submitting a marketing application for the peanut allergy drug AR101 by year-end 2018.
U.S. drug developer Aimmune Therapeutics Inc.’s peanut allergy drug met the main goal of an eagerly awaited late-stage study.
DBV Technologies’ Phase III peanut allergy trial failed to show a statistically significant response against placebo.
Aimmune Therapeutics said on Monday it would collaborate with Regeneron Pharmaceuticals and Sanofi to develop its experimental peanut allergy drug.