{"id":8787,"date":"2020-02-07T10:18:43","date_gmt":"2020-02-07T15:18:43","guid":{"rendered":"https:\/\/www.singlecare.com\/blog\/?p=8787"},"modified":"2020-07-10T13:57:46","modified_gmt":"2020-07-10T17:57:46","slug":"fda-approves-palforzia","status":"publish","type":"post","link":"https:\/\/www.singlecare.com\/blog\/news\/fda-approves-palforzia\/","title":{"rendered":"FDA approves first treatment for peanut allergy"},"content":{"rendered":"<p><span style=\"font-weight: 400;\">The U.S. Food and Drug Administration (FDA) has approved the first drug for the treatment of peanut allergy, an oral immunotherapy agent called Palforzia [Peanut (Arachis hypogaea) Allergen Power-dnfp]. It works by lessening the risk of a severe reaction if a child is accidentally exposed to this common allergen.\u00a0<\/span><\/p>\n<h2><span style=\"font-weight: 400;\">What is Palforzia?<\/span><\/h2>\n<p><span style=\"font-weight: 400;\">Palforzia, manufactured by<\/span><a href=\"https:\/\/www.aimmune.com\/\" target=\"_blank\" rel=\"noopener noreferrer\"><span style=\"font-weight: 400;\"> Aimmune Therapeutics Inc.,<\/span><\/a><span style=\"font-weight: 400;\"> is a powder that can be mixed with semisolid foods like applesauce, yogurt, or pudding for dosing. (It is important to know that the capsules are not meant to be swallowed.) The new drug is intended for children 4 to 17 years old. It\u2019s a preventative measure, but will not eliminate a peanut allergy.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Experts say it\u2019s important to know what Palforzia can do\u2014and what it can\u2019t do.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Children who take Palforzia should still avoid eating peanuts or anything containing peanuts. And they\u2019ll still need to carry their auto-injectable epinephrine devices, in case they experience an allergic reaction.<\/span><\/p>\n<h3><span style=\"font-weight: 400;\">Palforzia is a treatment, not a cure\u00a0<\/span><\/h3>\n<p><span style=\"font-weight: 400;\">\u201cWe want people to understand that it\u2019s not a cure,\u201d says <\/span><a href=\"https:\/\/www.stonybrookchildrens.org\/profile\" target=\"_blank\" rel=\"noopener noreferrer\"><span style=\"font-weight: 400;\">Susan Schuval, MD<\/span><\/a><span style=\"font-weight: 400;\">, chief of pediatric allergy and immunology at Stony Brook Medicine. \u201cIt\u2019s a treatment that lessens the risk of a severe reaction if you accidentally ingest peanuts.\u201d<\/span><\/p>\n<p><a href=\"http:\/\/ir.aimmune.com\/news-releases\/news-release-details\/fda-approves-aimmunes-palforziatm-first-treatment-peanut-allergy\"><span style=\"font-weight: 400;\">Over a million<\/span><\/a><span style=\"font-weight: 400;\"> children in the U.S. have a peanut allergy, and many of those kids have consumed peanuts without intending to\u2014even though <\/span><a href=\"https:\/\/acaai.org\/news\/peanut-allergies-accidental-exposure-and-severe-reactions-decline\" target=\"_blank\" rel=\"noopener noreferrer\"><span style=\"font-weight: 400;\">accidental exposures have decreased<\/span><\/a><span style=\"font-weight: 400;\"> in recent years. (Aimmune reports that 60% of children with peanut allergy have experienced an accidental encounter over a five-year span.) That creates a lot of anxiety for those children and their parents.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u201cThose families live in fear, and this will go a long way, if they\u2019re treated with this peanut product, to help alleviate those fears,\u201d says <\/span><a href=\"http:\/\/www.eallergy.yourmd.com\" target=\"_blank\" rel=\"noopener noreferrer\"><span style=\"font-weight: 400;\">J. Allen Meadows, MD<\/span><\/a><span style=\"font-weight: 400;\">, president of the American College of Allergy, Asthma, and Immunology (ACAAI).\u00a0<\/span><\/p>\n<h3><span style=\"font-weight: 400;\">Palforzia is a groundbreaking therapy<\/span><\/h3>\n<p><span style=\"font-weight: 400;\">\u201cIt\u2019s the first step [toward] a new horizon,\u201d Dr. Meadows says. <\/span><span style=\"font-weight: 400;\">\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Even people who can\u2019t take Palforzia because of their age or other circumstances should take note of the groundbreaking nature of this new treatment, agrees <\/span><a href=\"https:\/\/www.uchicagomedicine.org\/find-a-physician\/physician\/christina-e-ciaccio\" target=\"_blank\" rel=\"noopener noreferrer\"><span style=\"font-weight: 400;\">Christina Ciaccio, MD<\/span><\/a><span style=\"font-weight: 400;\">, associate professor and chief of allergy\/immunology at the University of Chicago Medicine.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u201cWhat they should feel is hope,\u201d says Dr. Ciaccio. \u201cEven if they are not ones who could benefit from this product or potentially benefit from this product, it\u2019s a first. It\u2019s the first FDA-approved treatment for food allergy.\u201d<\/span><\/p>\n<h2><span style=\"font-weight: 400;\">How does Palforzia work?<\/span><\/h2>\n<p><span style=\"font-weight: 400;\">There are two questions that may be on your mind, if you\u2019re considering Palforzia for your child: How long does it take to work, and how much will it cost?<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Dr. Schuval says it\u2019s a big time commitment. Palforzia has a structured dosing approach involving three phases of treatment, starting with an initial dose escalation under the direct supervision of a specially certified physician. A patient will then have to make regular trips to the physician\u2019s office as the dosage amounts are gradually increased (up-dosing).<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Later, when it\u2019s time to move to the maintenance phase, patients can continue therapy at home. They\u2019ll need to continue taking a daily dose of 300 mg indefinitely to maintain the desensitization effect.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">As for cost, according to Aimmune, the list price of Palforzia will be $890 per month, with a patient copay program that could reduce out-of-pocket costs significantly\u2014perhaps to as low as $20 per month. The cost will remain the same throughout the phases of treatment.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u201cAs a parent, the most important thing is to talk with your physician or allergist about Palforzia to see if it makes sense as a treatment option for your child,\u201d says Lisa Gable, chief executive officer of<\/span>\u00a0<a href=\"https:\/\/www.foodallergy.org\/\" target=\"_blank\" rel=\"noopener noreferrer\"><span style=\"font-weight: 400;\">FARE (Food Allergy Research &amp; Education)<\/span><\/a><span style=\"font-weight: 400;\">. \u201cImmunotherapies are complex given the incremental exposure to allergens and, in some cases, patients may experience an allergic reaction during the course of their treatment. The important thing to remember about Palforzia\u2019s approval is that it gives patients and their families an option and the opportunity to choose the treatment that is right for them.\u201d<\/span><\/p>\n","protected":false},"excerpt":{"rendered":"<p>The U.S. Food and Drug Administration (FDA) has approved the first drug for the treatment of peanut allergy, an oral immunotherapy agent called Palforzia [Peanut (Arachis hypogaea) Allergen Power-dnfp]. It works by lessening the risk of a severe reaction if a child is accidentally exposed to this common allergen.\u00a0 What is Palforzia? Palforzia, manufactured by [&hellip;]<\/p>\n","protected":false},"author":85,"featured_media":6926,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[4114],"tags":[4141],"coauthors":[9482],"class_list":["post-8787","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news","tag-fda-approvals","wpautop"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.4 (Yoast SEO v27.4) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>FDA approves first peanut allergy treatment: Palforzia<\/title>\n<meta name=\"description\" content=\"Palforzia is mixed with foods to lessen the risk of an allergic reaction to peanuts. 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