The FDA is finally reviewing a new drug for food allergies. This drug, Palforzia, is an oral immunotherapy tablet taken daily. Palforzia contains a small amount of peanut protein that aims to desensitize the immune system’s overreaction to peanuts. Over time, the patient will have less severe reactions to peanuts. APAC voted 7 to 2 that the efficacy data and 8 to 1 that the safety data, in conjunction with additional safeguards, are adequate to support the use of PALFORZIA. If approved, Palforzia would become the nation’s first approved treatment for peanut allergies. While there are high hopes of the drug being approved, there are some risks and additional information patients should know about food allergy treatments.
Palforzia was formerly known as AR101 while it was being developed and undergoing clinical trials. The drug is a powder that contains a precise dose of peanut flour. It is intended to treat children ages 4 to 17 that have been diagnosed with a peanut allergy. Palforzia is the first immunotherapy treatment that has undergone the full body of clinical trials necessary for the drug to be considered for approval. The drug was met with mostly positive responses and FDA approval is expected.
Risks of Palforzia
As with any drug, Palforzia poses some risks. For one, it could evoke a severe allergic reaction during the first use. During clinical trials, research showed an almost tripling of the risk of an anaphylactic reaction during the time the patient is building a tolerance to reach the maintenance dose. In some cases, patients’ peanut allergies actually worsened. Because of these risks, Palforzia is not safe for children under 4 years old. You should discuss any drug side effects with your physician.
Unapproved Oral Immunotherapy
There are other oral immunotherapy treatments that have not been FDA approved. These treatments involve consuming prescribed doses of peanut flour. Allergists that currently offer peanut oral immunotherapy either produce the peanut flour in their own labs or purchase it from third-parties that formulate the doses for them. Some families even give their children small amounts of peanut butter at home to build a tolerance. These unapproved forms of immunotherapy could end in a serious allergic reaction. If you are concerned about a food allergy in your family, book an appointment online or visit one of our allergy centers in NYC to discuss how we can help you manage your children’s allergies.
Why We Need FDA Approved Food Allergy Treatments
Although some allergists are already providing patients with unapproved oral immunotherapy, it’s safer to have an FDA approved form of treatment. We need approved food allergy treatments to ensure consistency from capsule to capsule. It will provide the certainty that each patient is getting the correct dose at the correct time. An FDA approved treatment will also encourage more physicians, like our Board Certified Allergists, to provide it to patients without worrying about liability. NY Allergy & Sinus Centers will keep you updated on the progress of the approval of Palforzia.
Meet The Physician Collaborator
Dr. Robert Tamayev is a physician specializing in both Pediatric and Adult Allergy & Immunology. He manages a wide spectrum of allergic diseases, including perennial and seasonal allergies, asthma, food allergies, eczema, hives (urticaria), and contact dermatitis. He is Board Certified by the American Board of Internal Medicine. You can schedule an appointment with Dr. Tamayev by calling (718) 416-0207 or booking an appointment online for our allergy center in Queens.