Aimmune submits BLA to FDA for peanut allergy therapy

Aimmune Therapeutics Inc. (NASDAQ:AIMT) submitted a BLA to FDA for AR101 to treat peanut allergy in children and adolescents ages 4-17.

The BLA includes data from the Phase III PALISADE trial. In February, Aimmune said AR101 met the primary endpoint of a greater proportion of patients who were able to tolerate a dose of at least 600 mg of peanut protein -- at least two peanuts according to Aimmune -- vs. placebo. In November, detailed safety data from PALISADE published in the New England Journal of Medicine showed a higher rate of rescue epinephrine use in the AR101 arm vs. placebo arm (see "Full Data for Aimmune Peanut Allergy Therapy Published in NEJM")...