The Food and Drug Administration (FDA) has approved Palforzia (Peanut [Arachis hypogaea] Allergen Powder-dnfp; Aimmune Therapeutics) for the treatment of peanut allergy.

Palforzia is an oral immunotherapy indicated for the mitigation of allergic reactions, including anaphylaxis, that may occur with accidental exposure to peanut. It is approved for use in patients with a confirmed diagnosis of peanut allergy in conjunction with a peanut-avoidant diet. 

Treatment with Palforzia may be initiated in patients aged 4 to 17 years. Up-dosing and maintenance may be continued in patients aged 4 years and older. The first dose of each dose escalation and up-dosing are required to be administered under the supervision of a healthcare professional equipped to treat severe allergic reactions. 

The approval was based on data from the phase 3 PALISADE trial which supported the efficacy of the investigational immunotherapy. The study met its pre-specified success criterion for efficacy with a significantly greater proportion of patients being able to tolerate a dose of at least 600mg of peanut protein with no more than mild symptoms, compared with placebo (67.2% vs 4.0%, respectively; P <.0001). 

With regard to safety, the most common adverse reactions observed were abdominal pain, vomiting, nausea, oral pruritus, oral paresthesia, throat irritation, cough, rhinorrhea, sneezing, throat tightness, wheezing, dyspnea, pruritus, urticaria, anaphylactic reaction, and ear pruritus. 

Palforzia is not indicated for the emergency treatment of allergic reactions, including anaphylaxis. Its use is contraindicated in patients with uncontrolled asthma or with a history of eosinophilic esophagitis and other eosinophilic gastrointestinal disease.

Additionally, Palforzia carries a Boxed Warning for the risk of anaphylaxis that can occur at any time during therapy. The treatment is available only through a Risk Evaluation and Mitigation Strategy (REMS) program. Under the REMS, only certified pharmacies and healthcare settings can dispense the product. Patients must be enrolled in the program prior to administration and must be informed of the need to have injectable epinephrine available for immediate use at all times.

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The product will be available as pull-apart color-coded capsules in 0.5mg, 1mg, 10mg, 20mg and 100mg strengths for dose escalation and up-dosing, and in 300mg sachets for maintenance treatment. The powder should be emptied onto a few spoonfuls of semisolid food (eg, applesauce, yogurt, pudding) and consumed; the capsules should not be swallowed.

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