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.

Key Questions:

  • 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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