FDA Panel Recommends Approval of First Therapy for Peanut Allergy
An FDA advisory committee has recommended the approval of the first therapy for peanut allergies.
Following a 7-2 vote in favor of effectiveness and 8-1 vote in favor of safety, the advisory committee recommended approval of Palforzia, an oral immunotherapy that uses fixed doses of powdered peanut sprinkled over food.
While the therapy is not expected to cure peanut allergy, it may help patients tolerate up to 1 peanut’s worth of the anaphylaxis-causing protein consumed accidently. If approved, Palforzia is expected to include a Black Box warning indicating that it should only be administered in certified facilities.
The final decision on approval from the FDA is expected in early 2020.
First peanut allergy therapy gets backing from U.S. regulators' expert advisers [press release]. September 13, 2019. Reuters. https://www.reuters.com/article/us-aimmune-peanutallergy/first-peanut-allergy-therapy-gets-backing-from-u-s-regulators-expert-advisers-idUSKCN1VY2FB. Accessed September 16, 2019.