Aimmune Receives FDA Approval for Palforzia; the First Treatment for Peanut Allergy

Aimmune Receives FDA Approval for Palforzia; the First Treatment for Peanut Allergy

Aimmune announced the U.S. FDA has approved Palforzia [Peanut (Arachis hypogaea) Allergen Powder-dnfp], making this the first approved treatment for patients with a confirmed diagnosis 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. Palforzia is to be used in conjunction with a peanut-avoidant diet. It is not indicated for the emergency treatment of allergic reactions, including anaphylaxis.

The FDA approval of Palforzia was based on seven clinical studies, including the pivotal Phase 3 PALISADE and RAMSES clinical trials. 

PALISADE (Peanut ALlergy oral Immunotherapy Study of AR101 for DEsensitization in children and adults) was an international, randomized 3:1, double-blind, placebo-controlled trial of the efficacy and safety of AR101 in a Characterized Oral Desensitization ImmunoTherapy (CODIT) approach in patients with peanut allergy. PALISADE enrolled 554 peanut-allergic patients ages 4–49, all of whom had to experience dose-limiting symptoms at or before the 100-mg dose of peanut protein in an entry double-blind, placebo-controlled food cha...

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