- The Washington Times - Monday, September 16, 2019

A Food and Drug Administration panel has overwhelmingly approved a treatment that could lessen the severity of allergic reactions to peanuts in children.

The FDA’s allergenic products advisory committee voted 7-2 Friday in favor of a peanut allergen powder called Palforzia to help treat children 4 to 17 years old.

The oral immunotherapy treatment could provide some relief from life-threatening allergic reactions such as anaphylaxis, in which an itchy rash appears, the throat swells shut and blood pressure drops precipitously.

“I believe it offers hope to families who have children who are highly allergic to peanut and will certainly give them some degree of assurance that their kid won’t have a calamitous anaphylaxis reaction with having a little bit of edge of protection,” said Ira Finegold, a member of the FDA advisory committee and chief of allergy for Mount Sinai West.

“This is not a cure for peanut allergy,” Dr. Finegold said. “This is a treatment that lessens the severity of an accidental ingestion.”



If approved for the market, the oral treatment would be given daily, first taken as a capsule and later mixed with food, gradually building up patients’ tolerance to peanuts.

Jonathan Spergel, chief of the division of allergy at the Children’s Hospital of Philadelphia, said the treatment is going to be wonderful for some patients and will help protect against cross contamination. The Children’s Hospital of Philadelphia was one of many sites involved in the clinical trials of Palforzia, which is made by the biopharmaceutical company Aimmune Therapeutics.

“It doesn’t let them go home and eat a bag of peanuts, but it lets them go out to an ice cream parlor and have an ice cream and let them worry less,” Dr. Spergel said, adding it will lessen the burden of fear of exposure and improve the quality of life for patients.

In clinical trials, participants started with 0.5 mg (about the size of a grain of salt) of the oral treatment and gradually increased their dosage to 300 mg (equal to one peanut) over six months.

In one double-blind, placebo-controlled food trial that included 555 patients, most of them between 4 to 17 years old, the peanut allergen powder treatment proved 63% more effective than the placebo.

The study included an initial dose escalation more than one to two days under clinical observation, an increase in dosing every two weeks and maintenance dosing of 300 mg of Palforzia daily.

The goal of the study was for patients to reach a tolerance of about two peanuts with mild symptoms, a measure about two-thirds of patients met after six months of gradual escalated dosage, Dr. Spergel said.

Lisa Gable, CEO of Food Allergy Research and Education (FARE), called food allergies a growing epidemic and said that those affected have no choice but to try to avoid the food and to carry around an EpiPen for emergencies.

“Right now, there are no choices for the patient,” Ms. Gable said. “We are at a point where the quality of life for these individuals and the risks, particularly for children and youth and young adults, is so extreme for the disease that we are pleased to see the first therapy moving into the market and hope that that gets others to invest in this space.”

She commented on the daily burden of having life-threatening food allergies, noting how those affected might not be able to board planes and have to worry about social interactions or eating out. “This disease can be so limiting for so many people,” she said.

Out of the 32 million people in the U.S. with food allergies, 25% are allergic to peanuts, according to Ms. Gable. About 1 in 13 children, or roughly two kids per classroom, have a food allergy, reports FARE.

The rise in food allergies started in 1998, Ms. Gable said, noting that a reason behind the rise is that doctors were telling pregnant people to avoid eating allergens and delay feeding kids these allergens until later in childhood.

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