The Food and Drug Administration last week approved the first drug to treat peanut allergies, which will go by the name Palforzia.
The approval was major news, and rightly so. It’s estimated that more than 1 million children in the United States have peanut allergies. Parents want help keep their kids safe, and until now the options have been limited.
“For peanut allergies, the treatment has always been avoidance. Just avoid, avoid, avoid — and then use epinephrine for when you have anaphylaxis,” explained Dr. Jonathan Spergel, chief of the Allergy Program at Children’s Hospital of Philadelphia, one of the research sites for the new medication.
“This therapy is a big deal,” Spergel said, “because it’s the first treatment beyond avoidance.”
But what does Palforzia do, and what does it mean for families at a practical level? Here’s what we know about the drug’s approval and what comes next.
1. The new drug will NOT cure peanut allergies.
The aim is, essentially, to make children slightly less allergic by reducing the reaction they have when exposed to peanuts.
“The goal is to raise your threshold,” said Dr. Scott Sicherer, director of the Elliot and Roslyn Jaffe Food Allergy Institute at the Icahn School of Medicine at Mount Sinai — also one of the sites where the drug was tested.
So, if your child currently has an allergic reaction when he or she is exposed to the equivalent of 1/10th of a peanut, Shicherer explained, the goal of this medication would be to get to a point where he or she can handle one whole peanut without an allergic reaction.
2. The treatment process is pretty long and involved.
The treatment consists of a strategy that has been used in food allergy circles for years: oral immunotherapy. By slowly and carefully exposing the body to increasing amounts of an allergen — in this case, peanuts — the treatment raises the threshold at which a reaction occurs. It’s not a one-time thing.
So, what does the process entail? To begin, parents should plan on bringing their child to the allergist for almost a full day, where they’ll start with the “teeniest” dose, Sicherer said — “like the dust of a peanut.” Kids will then be given incrementally bigger doses, about every 30 minutes, under close medical supervision — and then they’ll be watched some more. The next day, kids come back to take another dose in front of the doctor and be watched some more. Then kids come in every two weeks to get slightly higher doses.
In between those every-other-week visits — which Sicherer estimated will probably take at least two hours — the patient takes the medication daily at home. It comes in powder form in a capsule that is added to semi-solid foods like pudding or applesauce. A child goes through 11 increasing dose levels, and then may begin the daily maintenance dose. Along the way, doctors will closely calibrate dosage and work with families if children have reactions.
Again, it’s a process, not a one-and-done kind of deal.
3. You can’t buy Palforzia quite yet.
Just because the FDA has approved the medication does not mean it’s available to patients.
“The next step is when can your doctor go to the pharmacy and order it?” Spergel explained. “That typically takes a couple of months.” However, a representative for Aimmune — which manufactures the drug — told HuffPost it expects allergists will be able to begin prescribing the medication within a matter of weeks.
The other issue for families is how quickly a medication like this will be approved by insurers, which can also take time.
4. It’s certainly not for everybody ...
The FDA has approved the drug for children between ages 4 and 17 who have a diagnosed peanut allergy. But within that group are patients who may not be good candidates. For example, Palforzia is not those who have uncontrolled asthma, the FDA says.
And studies leading up to its approval showed some pretty serious potential side effects, like nausea, vomiting, hives, wheezing, and even anaphylaxis. It is essential that patients have epinephrine on them at all times to treat any potential incidents.
There’s also the cost. The price for Palforzia has been set at $890 a month, or roughly $11,000 per year. Again, because the medication is new, insurance coverage is still very much in the works.
All of that means parents should plan on having thorough discussions with their children’s health care providers weighing the risks and potential benefits, which makes this a highly personal decision, the experts emphasized.
But Sicherer said Palforzia might still be an appealing option for parents of children who have experienced accidental exposures to peanuts, despite their best efforts to avoid, avoid, avoid.
“You know, they’re trying to be careful, they’re talking to restaurants, but they’ve ended up having allergic reactions anyway because their children are very sensitive to a small amount,” Sicherer said.
The new drug “could be a great match,” he added, “for someone who wants to raise that threshold.”
Clarification: This story has been updated to include comment from Aimmune about the timing and accessibility of Palforzia.