FDA Approves Palforzia, But Should Address Prevention ReadySetFood – Ready, Set, Food!
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FDA Approval of Palforzia Underlines Need for Food Allergy Prevention

Ready, Set, Food!'s CEO Daniel Zakowski responds to the FDA's recent approval of the drug Palforzia for peanut allergy treatment. 

We were thrilled when the FDA recently approved Palforzia, the first of its kind drug designed to treat peanut allergies for children between 4 and 17 years old, but unfortunately it’s not a cure.  We applaud Aimmune Therapeutics, the makers of Palforzia and the FDA for its efforts in addressing this epidemic, but early allergen introduction is still the best option in working towards food freedom and decreasing the physical, social, emotional and financial impact on families and our healthcare system.

Recently, a multi-disciplinary group of 15 preeminent clinicians and allergists published a letter calling on the USDA to revise their dietary guidelines on childhood nutrition to reflect the evidence that shows we can prevent 200,000 babies from developing severe food allergies every year. They argue that overwhelming research proves that early and sustained allergen introduction is not only safe but can significantly reduce a child’s risk of developing food allergies by up to 80%. This also is why early allergen introduction is already recommended by the American Academy of Pediatrics and the National Institute of Health.

Today, 1 in 13 American children are burdened with a life-threatening allergy to common foods like peanut, egg, and milk.  This staggering statistic points to our country’s growing food allergy epidemic, but also overlooks the dramatic personal impact to quality of life. For example, my 3-year-old nephew can’t have a normal experience at birthday parties because of his life-threatening allergies to egg and dairy, which are in virtually every food at kid’s parties. In many schools, the fear of exposure to allergenic foods has caused children to be separated from their peers at lunchtime, making them feel isolated, singled out, and often bullied. 

Thankfully, multiple landmark studies (like the LEAP Study, New England Journal of Medicine, originally published 2/23/15 at NEJM.org) have shown that frequently feeding babies peanuts, eggs, and cow’s milk as young as four months old reduces the chances of developing food allergies by up to 80%. On the other hand, Palforzia and other therapeutics coming on the market do not cure or prevent food allergies, and they come with a high price. For many patients suffering from food allergies, these treatments are cost-prohibitive. The price of Palforzia is projected to be $11,000 per year for each patient that may use it for up to 13 years, and patients must continue to avoid allergenic foods and carry EpiPens to manage potentially severe reactions. 

While Aimmune’s breakthrough and the FDA’s approval of Palforzia is an important moment for families with existing food allergies, as a society we must also focus on the primary goal to introduce food allergens early and drastically diminish this epidemic. That means early allergen introduction needs to be a major part of the conversation.

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