Focus of the Report: Use of oral immunotherapy (OIT) with Palforzia (formerly AR101) for the management of peanut allergy.
Technology Description: Palforzia (peanut allergen powder-dnfp) is an oral immunotherapy (OIT) treatment comprising a proprietary formulation of peanut protein manufactured from defatted peanut flour combined with pharmaceutical-grade ingredients. The powder is provided in capsules or a sachet containing gradually escalating doses from 0.5 to 300 milligrams (mg). Management with Palforzia consists of 3 phases: initial dose escalation, up-dosing, and maintenance. Palforzia is not proposed as a cure for peanut allergy. It is proposed to desensitize allergic patients to amounts of peanut protein greater than the amount of a typical accidental exposure. Patients managing their allergy with Palforzia will still need to carry an epinephrine auto-injector and avoid peanut-containing foods.
Controversy: Studies have shown OIT to be efficacious in inducing a desensitized state in patients; however, efficacy has been measured during oral food challenges. It is unknown whether desensitization is sustainable and can protect patients from real-world exposures. In addition, it remains to be seen whether a potential increased risk for side effects associated with OIT outweighs the potential benefit of desensitization.
Is Palforzia effective in managing peanut allergy?
Is Palforzia safe for managing peanut allergy?
Have definitive patient selection criteria been identified for the use of Palforzia?
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