14 Feb The Peanut Pill is Now FDA Approved
The peanut pill, Palforzia, has been approved by the FDA, so what are food allergy patients supposed to think?
Here is what we know:
Palforzia is a patented capsule that contains peanut flour. It is prescribed to treat ages 4 to 17 with a confirmed diagnosis of peanut allergy through an oral desensitization process called oral immunotherapy (OIT). The goal is to be slowly desensitized to 300 mg of peanut protein or approximately one peanut . The process includes allergy office visits every 2 weeks for dose increases and observation during the initial build up phase.
Because of the risk of severe allergic reactions, Palforzia will only be available through a restricted program called the Palforzia Risk Evaluation and Mitig ation Strategy (REMS) program. Allergists prescribing Palforzia as well as patient’s taking the d rug will be required to participate in the REMS program. Family Allergy & Asthma Care and the Food Allergy Institute have already started the process to become REMS certified.
After completion of a buildup phase , Palforzia will help mitigate allergic reactions, including anaphylaxis, that may occur with accidental exposure to peanuts . Those who take Palforzia must continue to avoid peanuts in their diet. Studies have shown than 67.2% of Palforzia desensitized patients tolerate d an oral challenge of two peanuts.
The list price for Palforzia has been set at $890 per month or $11,000 per year , with the potential for a copay assistance program This will not cover office visits for administration of the product in a safe environment.
Palforzia is not yet available for purchase, but it will likely be available within in the next few months.
The great news is that Family Allergy & Asthma Care and the Food Allergy Institute already offer peanut oral immunotherapy treatment programs! The OIT program at FAI uses real peanuts and peanut products like peanut flour and peanut butter to safely accomplish desensitization. In addition, FAI provides desensitization to multiple other foods including all tree nuts, egg, milk, wheat, and sesame in children (as young as 12 months) as well as adults. The OIT program at FAI allows participants to progress past the 300mg dose with the potential to eat freely.
The Food Allergy Institute was founded in 2014 Drs. Hudelson, Fitzgerald and Alvarado have extensive training and have expertise in OIT To date more than 150 OIT patients have been successfully treated through the Food Allergy Institute . FAI provides direct supervision of OIT patients in a specialty suite staffed by skilled Physician Assistants and nurses OIT patients have accessibility to providers 24 hours per day .
We would love to answer your questions and help you navigate through all the exciting options to determine your best care!
Call us today to schedule your food allergy consultation! 972-539-0086