FDA Approves Palforzia for Treatment of Peanut Allergy

Our providers and staff at Allergy, Asthma & Food Allergy Centers are excited to learn of the FDA’s decision to approve Palforzia as the first “drug” for the treatment of peanut allergy, as this signifies greater acceptance of oral immunotherapy (OIT) as mainstream treatment for life-threatening food allergies.

Based on our 3+ years of direct experience treating peanut-allergic patients with OIT and the collective 10+ years of experience from other private practice OIT centers across the country, the safety and efficacy data of the Palforzia “drug” is comparable to our method of using readily available sources of peanut protein to perform oral desensitization. This is where the similarities end.

First, the highest treatment dose of Palforzia is 300 mg of peanut protein, about the equivalent of 1 whole peanut or 1/4 teaspoon of peanut butter. Thus, the primary goal of this drug is to raise the threshold of having an allergic reaction to an accidental ingestion of peanut protein (“bite-proof”), which in itself can be a remarkable achievement for peanut allergy sufferers. On the other hand, our protocol is designed to allow patients to reach a daily maintenance dose of 2000 mg (2 grams) of peanut protein, equal to 8 whole peanuts or 2 teaspoons of peanut butter. Furthermore, this maintenance dose actually allows them to safely ingest at least 6000 mg (6 grams) of peanut protein, equal to 24 whole peanuts or 2 tablespoons of peanut butter. This provides the majority of our patients the freedom to eat any amount of peanut protein they wish. That being said, each patient and family may have a different safety goal in mind, and our OIT protocol also provides the flexibility to achieve this goal.

Second, Palforzia is only approved for the treatment of peanut-allergic patients between the ages of 4 and 17 years. Our OIT program has no age limits. In fact, some of our most impressive outcomes have been seen in our infants with peanut allergy!

Additionally, there is no OIT “drug” close to FDA approval for the treatment of food allergies other than peanut. We currently have patients undergoing OIT for egg, milk, tree nuts, wheat, soy and sesame.

Finally, the company that makes Palforzia has set the annual price for their “drug” at $10,680 (or $890 per month) with no guarantee of health insurance coverage at this point. Our current OIT patients/families will spend on average less than $200 in total for peanut flour capsules supplied by a local compounding pharmacy. Beyond that, they are using store-bought roasted peanuts or peanut butter. Palforzia may simply not be a cost-effective option, especially for the level of protection it will provide for those with peanut allergy.

For those of you interested in learning more about all treatment options for peanut allergy, please call our office to schedule an appointment with one of our board-certified allergists. As always, Drs. Borts, Warrier and Vitale are accepting new patients in our main (Sunset Hills, MO) office. Furthermore, Dr. Palis primarily sees new patients in our Swansea, IL office, only 15 miles east of downtown St. Louis.