The Food and Drug Administration (FDA) is one step closer to approving a therapeutic intervention for peanut allergy. After reviewing the safety and efficacy of a standardized oral immunotherapy product for peanut allergy, the Allergenic Products Advisory Committee of the FDA voted favorably on Friday to support approval of Palforzia (previously referred to as AR101), manufactured by Aimmune. Palforzia’s indication for treatment is for patients 4 to 17 years with a confirmed diagnosis of peanut allergy, to reduce the incidence and severity of allergic reactions, including anaphylaxis, after accidental exposure of peanut.
The FDA will require Aimmune to develop a Risk Evaluation and Mitigation Strategy (REMS), as well as a “black box” warning in the prescribing information. The REMS will need FDA review and approval.