First peanut allergy treatment approved by FDA

Peanut allergy is one of the most common food allergies in the world, affecting more than 1.6 million children and teens in the United States alone.1,2 A first-of-its-kind treatment for patients with peanut allergy is now available. The U.S. Food and Drug Administration (FDA) announced approval of Palforzia®, by the manufacturer Aimmune Therapeutics, Inc., as of January 31, 2020. This new oral immunotherapy drug works to prevent or decrease chances of severe allergic attack upon accidental exposure to peanuts.

Treatment with Palforzia initiates in children ages 4-17. Treatment begins over the course of several months. Patients receive a gradual increase in dosage from 3 mg per day to a maintenance dose of 300 mg per day – about the same amount of protein as in one peanut. The first doses at each increasing level must take place in a health care facility, staffed and equipped to manage severe allergic reactions. A minimum of 12 office/health care facility visits are necessary to reach maintenance dosing. Individuals of 18 years or older can continue to take this drug if they initiated treatment at some point between the ages of 4-17.

Palforzia will be designated as not-covered on Cigna’s formularies initially, with medical necessity review available. Palforzia will be classified as a Specialty drug. Cigna will conduct a comprehensive review evaluating the clinical safety and efficacy, the medication’s overall value, and other factors before making a coverage decision.

Currently available treatments for peanut exposures include emergency administration of epinephrine.  A second possible peanut immunotherapy, Viaskin® Peanut (DBV Technologies), a daily skin patch formulation intended for children age 4-11 years, has an FDA action date of August 5, 2020.

  1. United States Census Bureau Quick Facts (2015 estimates). <http://ir.aimmune.com/news-releases/news-release-details/fda-approves-aimmunes-palforziatm-first-treatment-peanut-allergy>
  2. Gupta R, Warren C, Blumenstock J, et al. OR078 The Prevalence of Childhood Food Allergy in the United States: An Update. Ann Allergy Asthma Immunol. 2017;119(5 Suppl): S11. <http://ir.aimmune.com/news-releases/news-release-details/fda-approves-aimmunes-palforziatm-first-treatment-peanut-allergy>

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