FDA approves 1st treatment for kids with peanut allergy

Uses small doses of special powder

WASHINGTON — The first treatment for peanut allergies is about to hit the market, a big step toward better care for all kinds of food allergies — but still a long way from a cure.

Friday’s approval by the Food and Drug Administration promises to bring some relief to families who’ve lived in fear of an accidental bite of peanuts at birthday parties and play dates, school cafeterias and restaurants. Named Palforzia, it was developed by Aimmune Therapeutics.

“It’s been a life-changer,” said Nina Nichols, 18, of Washington, whose first encounter with peanuts as a toddler — a peanut butter cracker shared by a friend — required a race to the emergency room. She entered a Palforzia research study as a teen and calls it “a security blanket.”

The treatment is a specially prepared peanut powder swallowed daily in tiny amounts that are gradually increased over months. It trains childrens’ and teens’ bodies to better tolerate peanuts so that an accidental bite is less likely to cause a serious reaction or even kill in severe cases.

Palforzia users still must avoid peanuts just as they always have.

The treatment is not for everyone. Palforzia can cause side effects, including occasional severe allergic reactions. The FDA is requiring that doctors and their patients enroll in a special safety program, and patients must take the first dose and each increased dose under supervision in a certified health center.

And if youngsters stop taking the daily dose, they lose the protection.

Shots have long been used to induce tolerance for allergies to bee stings or pollen. But swallowing an allergen to build tolerance is a new twist — one that scientists call “oral immunotherapy.” And peanuts are just the first food to be tackled. Tests for eggs, milk and tree nuts are underway.

But because of the drawbacks, scientists also are developing next-generation options that work differently. Next up for FDA review: A skin patch for peanut allergy.

Aimmune executives said Friday they hope doctors can begin prescribing the treatment in “a matter of weeks.” They set the treatment’s list price at $890 a month, but how much patients will pay depends on their insurance. Aimmune says it is working with insurance companies for coverage and will offer a patient co-pay assistance program.

Millions of Americans have food allergies, including about 1 in 13 children, and the numbers have increased in recent years. Peanut allergy is the most common one among children and among the most dangerous. Accidental exposures are frequent.

The immune system overreacts to the food by triggering an inflammatory cascade. On average, children can experience hives, wheezing or worse from just a 30th of a peanut, sometimes even less, said Dr. Hemant Sharma, who leads oral treatment studies at Children’s National Hospital in Washington.

Doctors prescribe a minuscule Palforzia starting dose. The powder, stored in a capsule, is mixed into any unheated food, such as Ms. Nichols’ favorite fruit smoothies. Patients take the first dose in a doctor’s office, in case of a bad allergic reaction.

Palforzia users still must carry their rescue medicine, such as EpiPens, to treat severe allergic reactions. Most experience at least mild side effects, such as hives or stomachaches, and about a fifth dropped out of the study, said Dr. Scott Sicherer, a pediatric allergist at Mount Sinai Hospital in New York.

As for severe reactions, they struck about 9% of patients treated in the Palforzia study, nearly three times the number in the placebo group and prompting debate about the drug’s usefulness.

“There is a trade-off,” Dr. Sicherer said. Families and doctors together will have to decide “does it make sense for me or my child?”