FDA-Approved Palforzia—A Cure for Peanut Allergy?

If you’re tuned into the food allergy world, you probably heard that on January 31st, 2020, the FDA approved the first oral immunotherapy (OIT) drug for treating peanut allergy in children: Palforzia.
 
Since the announcement, we’ve been flooded with questions about what this means for peanut allergy families: What is Palforzia? Is it a cure? Can the drug help reduce the severity of my symptoms?
 
We compiled the top questions you asked, and put them together for this special edition post.  

1. What is Palforzia?

   
   Palforzia is essentially peanut flour in pill form. Aimmune Therapeutics is the company behind the drug, and the purpose of the pill is to reduce the severity of allergic reactions (including anaphylaxis) by ingesting daily microdoses of peanut powder.

2. Who is a candidate for OIT with Palforzia?

   
   Treatment can start as young as four and is intended for anyone with a peanut allergy. Notably, a clinical diagnosis of peanut allergy is required to begin treatment, and those who start treatment must avoid peanut in their diet otherwise. Treatment must also be taken daily, as skipping doses can increase the risk of reaction to subsequent treatments.
    
   Not everyone is a candidate for OIT. According to the FDA, if a patient has uncontrolled asthma, they are not advised to take this drug. Additionally, it’s essential that patients have epinephrine on them in case of possible anaphylaxis while taking Palforzia.

3. What’s the cost? 

   
   The price for Palforzia has been set at $890/month, or almost $11,000/year. Because this drug is new, insurance coverage is still in the works. However, we’ve heard that Aimmune will offer an assistance program to drop the patient’s share of the cost to as low as $20/month.

4. How is the drug administered? 

   
   There are three phases for administration: dose escalation, up-dosing, and maintenance. Palforzia is packaged as color-coded capsules for dose escalation and up-dosing. The peanut powder is emptied from the capsule and mixed with a small amount of food (e.g., pudding or applesauce) for ingestion.
    
   The first phase of treatment and the first dose of EACH subsequent up-dose MUST be administered in a certified healthcare setting equipped to monitor and treat patients in the event of anaphylaxis.

5. What’s the time commitment? 

   
   Typically, families will spend at least a few hours at the doctor’s office for dose escalation, and an hour or two for up-dosing visits. In between those visits, the patient will take the medication daily at home.

6. How long does treatment last? 

   
   The total treatment period can last 6 months or longer, after which point the patient continues to take a daily maintenance dose to sustain sensitization. The first dose may be the equivalent of 1/600th of a peanut, with the goal of reaching 300mg of peanut protein (approximately 1 peanut).

7. Who can prescribe Palforzia? 

   
   The FDA will require a REMS with this approval. In other words, Palforzia will only be available through certified healthcare providers, settings, and pharmacies to patients enrolled in the REMS program. These providers must be educated on the risk of anaphylaxis associated with its use.

8. Is this a cure for peanut allergy? 

   
   No, it is not a peanut allergy cure. Palforzia is designed to raise an individual’s threshold of tolerance to peanut in case of accidental exposure. Essentially, the goal is to get the patient’s immune system to tolerate a larger amount of peanut before it reacts.

We hope this answers your questions! We’ll be sure to keep you posted on Palforzia’s progress as the drug enters the market.

- The Allergy Amulet Team

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This piece was reviewed by Allergy Amulet advisors Dr. John Lee and Dr. Jordan Scott. 
 
Dr. John Lee is an allergist and the Clinical Director of the Food Allergy Program at Boston Children’s Hospital. 

Dr. Jordan Scott is an allergist and operates several private allergy clinics throughout the Boston area.