1st peanut allergy therapy gets FDA panel’s backing
AUS Food and Drug Administration advisory panel recommended approving the first therapy for peanut allergies, which affect over 1.6 million children in the US, despite raising concerns about the risk of severe allergic reactions it poses to young patients.
The body of independent advisers voted 7-2 in favour of effectiveness and 8-1 backing safety of the therapy Palforzia, developed by Aimmune Therapeutics. The verdict of the panel is an influential factor in the agency’s final decision. The FDA is expected to make a decision on approval early next year.