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New Peanut Allergy Pill for Kids Approved

The FDA last week approved Palforzia, which was shown to lessen kids' allergic reaction to peanuts during clinical trials, including at CHOP.




By PiccoloNamek at English Wikipedia

Updated: Feb. 5, 2020

The FDA has approved the first drug to treat kids with peanut allergies.

Palforzia is a "first-of-its-kind" treatment, says the Children's Hospital of Philadelphia, which was a research site for testing the drug.

Kids between 4 and 17 with peanut allergies will be given peanut protein under medical supervision to build up a tolerance and then, if they respond well, will take a daily maintenance dose.

While they still must avoid eating peanuts, the treatment has been shown to lessen the chance of a severe allergic reaction to an accidental exposure to peanuts at school, away at camp or at a restaurant, for example. Nearly 70 percent of the kids in the clinical trial were able to tolerate a 600 mg dose of peanut protein, the U.S. Food and Drug Administration says.

“While it’s not a cure, it will allow patients to live their lives with less fear of having a serious or fatal reaction to accidentally ingesting peanut protein,” says Jonathan Spergel, MD, PhD, section chief of CHOP's Food Allergy Center.

Some studies, however, have shown that patients taking the pill had more allergic reactions outside of the doctor's office.

"In patients with peanut allergy, high-certainty evidence shows that available peanut oral immunotherapy regimens considerably increase allergic and anaphylactic reactions over avoidance or placebo, despite effectively inducing desensitisation," said a study in The Lancet.

One child's story

Taking away that threat of a severe reaction can "transform a child's life," says Terri F. Brown-Whitehorn, MD, attending physician in the Food Allergy Center, and CHOP described the impact on a child who took part in the study of the drug.

Noah accidentally ate peanuts when he was six, triggering a serious reaction. A year later he entered the clinical trial. Although he was given a placebo, after the trial was over he was put on Palforzia and eventually developed an immunity to eating the equivalent of 18 peanuts. 

“Before I took the drug, I had to be so careful and look at ingredients all the time,” Noah says. "I really didn't want to be so frantic about my food allergies and have to worry every time I went somewhere.”

Noah's parents said they didn't realize how fearful Noah's allergies had made him until they read his respones to surveys he was given during the clinical trial.

"Noah wrote about how he felt, and we wrote about how we thought he felt,” says his father, Craig. “Reading his reactions later was heartbreaking. He hid from us that it made him feel isolated, scared and afraid of dying."

Push for allergy treatments

Some food-allergy advocates have been pushing for FDA-approved treatment alternatives.

"Peanut allergy carries an overwhelming psychosocial burden that impacts patients and their families daily – peanuts are everywhere, and the threat of a severe reaction related to an accidental peanut exposure dominates families’ daily lives,” says Lisa Gable, Chief Executive Officer, Food Allergy Research and Education (FARE), said in a press release from the company it started, Aimmume, to develop the pill.

Doctors who want to prescribe the drug must be enrolled in a Risk Evaluation and Mitigation Strategy (REMS) program, which the FDA says assures the drug will be administered where a child's reaction to the early doses can be monitored for anaphylaxis.

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