Palforzia was recently approved by the FDA to treat peanut allergy, the first “drug” of its kind. (Palforzia’s active ingredient is actually peanut allergen, in very small doses, but since it’s marketed as a treatment, it must be regulated as a drug.)
Other companies have sold products that aim to prevent peanut allergy, and eating peanuts early in life may help. But this is the first product meant to treat peanut allergy in children who already have it. It’s a product with pros and cons, though, so here’s what you should know if you’re interested.
The treatment won’t make it totally safe to eat peanuts
Palforzia isn’t a cure, and your kid won’t be eating peanut butter sandwiches after taking it. As an FDA official puts it:
Even with strict avoidance, inadvertent exposures can and do occur. When used in conjunction with peanut avoidance, Palforzia provides an FDA-approved treatment option to help reduce the risk of these allergic reactions in children with peanut allergy.
The idea is that small doses of peanut allergen can desensitize your child’s immune system just enough that accidental peanut exposures become less dangerous. They will still need to avoid peanuts.
There are three phases to treatment
The first phase, called Initial Dose Escalation, is a one-time dose that happens under medical supervision in case a severe reaction would occur. The peanut powder, packaged in capsules, is mixed into a semi-solid food such as yogurt, and the child eats the food. Children age 4 to 17 can start the therapy.
Then come 11 Up-Dosing levels, each consisting of a higher dose of peanut allergen. The first day of each of level is also done under medical supervision, and the others at home. The process can take several months.
After this is a Maintenance stage, in which the person needs to mix a packet of the powder into food (again, they recommend something like yogurt) every day.
It’s effective in many but not all patients
In a trial of about 500 peanut-allergic people, 67% were able to tolerate a 600mg dose of peanut allergen after taking the course of Palforzia. This is typical of the results for oral immunotherapy protocols; others, like milk and egg, are being studied as well, but so far this peanut product is the only one officially on the market.
If the child doesn’t continue taking the maintenance dose, their protection may decrease. But, again, it’s hard to predict how any one person will react.
It’s expensive
Palforzia’s maker, Aimmune, has set the price at $890 per month. It’s the same cost no matter which stage of the protocol you’re in. The company offers an assistance plan that it says can reduce out-of-pocket costs to $20 per month.
A spokesperson for Aimmune tells us that it’s “available through medical exception” (meaning you can try asking your insurance company to cover it, even if they don’t usually) and that they are hoping to get it covered under most insurance plans this year.
When I asked if the maintenance treatment needs to be continued for life, their response was: “PALFORZIA must be taken every day to maintain the treatment effect. We expect longer-term clinical studies to show the continued benefit to staying on PALFORZIA.”
The protocol is dangerous, but so is peanut allergy
Since Palforzia consists of peanut allergens, it’s possible that a child who takes it may develop an allergic reaction, including anaphylaxis, which can sometimes be fatal even with the best emergency care.
Because of this, the treatment can only be dispensed under the terms of a Risk Evaluation and Mitigation Strategy, or REMS. That means that doctors and pharmacists must be specially certified to be able to provide it, and there are rules surrounding the treatment. For example, your doctor will make sure you have an epi-pen and know how to use it, and that you understand you still must avoid peanut products.
Between the risk and the cost, the treatment may not be worth it to many families. But an untreated allergy also carries a risk of anaphylaxis, so on balance it may be worth the risk. If the treatment sounds like it might be a good idea for your child, talk it out with their pediatrician.
Updated 2/5/2020 at 10am to include new information from Aimmune on the maintenance phase and insurance coverage.