FDA News

FDA designates oral immunotherapy as breakthrough for children with peanut allergy

Aimmune Therapeutics announced its lead investigational product, AR101, for oral immunotherapy of children and adolescents aged 4 to 17 years with peanut allergy has received breakthrough therapy designation by the FDA, according to a press release.

“We are very grateful for the FDA’s recognition of the large impact AR101 could have in reducing the incidence of life-threatening allergic reactions in people with peanut allergies,” Stephen Dilly, PhD, CEO of Aimmune Therapeutics, said in the release. Currently, there are no approved medical therapies to treat the more than 2 million children and adolescents in the U.S. and Europe with peanut allergy who are vulnerable to reactions from accidental exposures. “We are eager to working closely with the FDA and to receive its guidance to help make AR101 available in patients as soon as possible.”

Aimmune Therapeutics recently announced results of a phase 2 randomized, double blind, placebo-controlled study of AR101 for desensitization treatment of peanut allergy. All of the patients who completed the treatment regimen (n = 23) tolerated exposure to a cumulative amount of at least 443 mg of peanut protein, and 78% of those patients tolerated exposure to a cumulative amount of 1,043 mg of peanut protein.

Aimmune Therapeutics plans to initiate a phase 3 confirmatory registration trial of AR101 for the desensitization of peanut allergy in children and adults, according to the release.