FDA to Assess First Peanut Allergy Drug

From the WebMD Archives

MONDAY, Sept. 16, 2019 -- A panel of experts at the U.S. Food and Drug Administration is set to weigh the pros and cons of what could be the first drug ever approved to prevent peanut allergy.

The medicine is called Palforzia, and its capsule contains a pharmaceutical-grade dose of the peanut protein. It's called "exposure therapy," aimed at safely desensitizing children to potentially life-threatening peanut allergy.

In one clinical trial, kids who took Palforzia for a year were eventually able to tolerate the equivalent of two peanuts, the Washington Post reported.

But the drug had a downside, too: An increase in allergic reactions plus the need for injections with an epinephrine "pen" to ease those reactions, the Post noted.

No one is calling Palforzia a cure for peanut allergy: Patients will still need to avoid peanuts and carry devices to treat an allergic reaction in an emergency. It's hoped, though, that Palforzia might help ease concerns about inadvertent exposure to peanut in small amounts.

The drug's maker, Aimmune, is seeking FDA approval for kids ages 4 to 17.

"For a family with high anxiety and a significant burden of anxiety and fear from living with peanut allergy, this might give that extra buffer of safety," Marcus Shaker, a pediatric allergist at Dartmouth's Geisel School of Medicine, told the Post.

"They're still going to need to strictly avoid peanuts, but [this will help] to let go of some of the fear they may have," said Shaker, who wasn't involved in the clinical trial.

That trial involved 551 people, 496 of them children. About a tenth of people in the trial dropped out due to side effects such as allergic reactions, abdominal pain or vomiting, the Post said. Fourteen percent of people who did have an allergic reaction needed to use an epinephrine pen to ease that reaction, twice as many as in the arm of the trial where patients got a "dummy" placebo pill.

All of that has patients and researchers uncertain as to which way the FDA panel will decide.

"I think we need more data on what it's going to mean to patients and how it's going to change their level of risk perception and change their quality of life," Shaker said. He believes Palforzia is "a little bittersweet for everybody. Everyone's happy to see something happening, and yet it's not what we asked for from Santa Claus."

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