On Friday the US FDA approved Palforzia to mitigate allergic reactions, including severe reactions such as anaphylaxis, from accidental exposure to peanuts.
The drug is approved for use only in patients with a diagnosed peanut allergy. Treatment is a three-phase process with an initial dose followed by dose escalation and then a maintenance program.
Patients must continue to avoid peanuts while on the drug, but clinical efficacy trials showed that 67.2% of Palforzia recipients tolerated a 600 mg dose of peanut protein compared to 4.0% of participants who received placebo instead of the drug.
Palforzia is manufactured from peanuts and dosed as a powder or capsules added to semisolid food such as applesauce. It works by allowing the patient’s body to build a tolerance to small controlled doses over time. Some doctors already try to treat peanut allergy with oral immunotherapy but Palforzia will allow standardized potency dosed in a controlled setting.
According to Medpage Today, in 2018 studies estimated 2.2% of the non-adult US population had peanut allergies, and about half of these patients had at least one severe reaction (anaphylaxis and/or an ER visit). Most experts agree that food allergies overall are increasing. It isn’t known why although food allergy is thought to be at least partially genetic.