'Breakthrough' status granted to Aimmune's peanut allergy drug
This article was originally published in Scrip
The FDA has granted breakthrough therapy designation (BTD) to Aimmune Therapeutics' investigational oral immunotherapy for peanut allergy, known as AR101.
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Palforzia was associated with a higher rate of adverse events, systemic allergic reactions, eosinophilic esophagitis and epinephrine use in controlled clinical trials; Allergenic Products Advisory Committee will weigh approval for patients ages 4-17 years with confirmed peanut allergy diagnosis.
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Even better than expected efficacy and safety in the Phase III PALISADE trial puts Aimmune on track to file its BLA for peanut protein capsule AR101 by the end of 2018.