MARY LOUISE KELLY, HOST:
For parents with kids who are allergic to peanuts, one of the biggest fears is, what happens if my kid accidentally eats something that contains traces of peanuts? - because the result can be life-threatening reactions such as swelling, trouble breathing, reactions that can prove fatal. Today an FDA advisory panel recommended that the agency approve a treatment for peanut allergy in children from 4 to 17 years old. Here to tell us more is NPR's Maria Godoy.
Hey there, Maria.
MARIA GODOY, BYLINE: Hey, Mary Louise.
KELLY: So what is this treatment? And how does it work?
GODOY: It's called Palforzia, and it's an experimental peanut allergy treatment from a company called Aimmune Therapeutics. It's basically protein - a peanut protein in a powder form. And it's given as a form of oral immunotherapy. So kids are given this peanut protein powder in increasing, controlled doses. And every two weeks, they ramp up the dose until they hit a target of 300 milligrams, which is the equivalent of about one peanut.
And the idea is not that they're cured of their allergy. If you have peanut allergies and you get this therapy, you're still going to have to carry an EpiPen. You're still going to have to avoid peanuts. But the idea is that it would reduce the severity and number of reactions. So if you accidentally eat something that's tainted with peanuts, your reaction would be less severe. So it's a little bit of an extra margin of safety.
KELLY: It's almost reminding me, like, of a bee sting shot. You still wouldn't want to get stung by a bee if you're allergic, but you may be - it helps you build up a little bit of tolerance. Is this safe?
GODOY: Well, studies show that the therapy does work, but it has substantial side effects. The FDA advisory committee today reviewed data from a large study of about 500 kids aged 4 to 17. After a year of therapy, most of those kids could tolerate exposure to the equivalent of two peanuts, and they had only mild symptoms. But they also had more severe reactions, allergic reactions. And they had to use their EpiPens more often than kids who were getting a placebo therapy. The most common reactions were gastrointestinal problems like abdominal pain and vomiting, as well as systemic allergic reactions. Those reactions did go down, lessen over time. Some kids had more severe reactions like inflammation of the esophagus, although that got better when they stopped therapy.
KELLY: But it sounds like some fairly worrying and deeply unpleasant side effects. Is the panel's thinking that these tradeoffs are worth it?
GODOY: That was really the question before the advisory panel today. In that study I mentioned, 1 in 10 patients actually ended up stopping treatment because of their adverse reactions. And so the kids who were able to tolerate exposure to peanuts, they actually did so when they were challenged by, you know, eating peanuts in a controlled setting. And the question raised in today's hearings - or one question raised was, how is this going to work in real world if you accidentally ingest peanuts? And as one member of the FDA advisory panel put it today, you know, they voted yes, we are - they recommended approval. Basically, they were taking a reasonable leap of faith that this will work. But the FDA does want to see some safeguards like, for instance, people who are getting the therapy should carry an EpiPen with them at all times.
KELLY: Sure. And just briefly, this panel recommends it. Does that mean the FDA will approve it? What happens?
GODOY: The FDA will have to go over the panel's deliberations. It actually usually goes with whatever the advisory committee says. It's expected to issue a final decision in January.
KELLY: All right, we shall watch and wait and see. That's NPR's Maria Godoy.
Thank you.
GODOY: Thank you. Transcript provided by NPR, Copyright NPR.
