Two days after a fairly benign review from FDA staff, an independent panel of experts largely endorsed the efficacy and safety of Aimmune?s peanut allergy therapy, laying the groundwork for approval with a risk evaluation and mitigation strategy (REMS).
Traditionally, peanut allergies are managed by avoidance, but the threat of accidental exposure cannot be nullified. Some allergists have been dosing patients off-label with peanut protein derived from supermarket products to wean them off their allergies. The idea behind Aimmune?s product was to standardize and premeasure the peanut protein, and track the process of desensitization so when accidental exposure in the real world invariably occurs, patients are less likely to experience a life threatening allergic reaction.
The drug, christened as Palforzia, was tested in two l
