Jan 31, 2020: The first treatment for peanut allergies is about to hit the market, developed by Aimmune Therapeutics, a big step toward better care for all kinds of food allergies — but still a long way from a cure.
Food and Drug Administration promises to bring some aid to families who have lived in fear of an accidental bite of peanuts at birthday parties and play dates, school cafeterias and restaurants.
The treatment is a particularly prepared peanut powder swallowed daily in tiny amounts that are gradually increased over months.
It trains children’s and teens’ bodies to better tolerate peanut so that an accidental bite is less likely to cause a severe reaction, or even kill in severe cases. Palforzia users still must avoid peanuts as they always have.
Also, the treatment is not for everyone. Palforzia can cause side effects that includes occasional severe allergic reactions.
The FDA is requiring that doctors and their patients enroll in a special security program, and patients must take the first dose and each increased dose under supervision in a certified health center.
Shots have long been used in order to induce tolerance for allergies to be stings or pollen. But swallowing an allergen to build tolerance is a new wind — one that scientists call “oral immunotherapy.”
And the peanuts are just the first food to be tackled. Tests for eggs, milk and tree nuts are in progress.
FOOD ALLERGY IS A RISING PROBLEM: Millions of the Americans have food allergies together with about 1 in 13 children, and the numbers have increased in recent years.
Peanut allergy is most common one between children, and with the most dangerous. Accidental exposures are normal, with about 1 in 4 affected children twisting up in the emergency room every year.
WHAT HAPPENS: “The immune system overreacts to food by triggering an inflammatory cascade. On average, children can experience rash, wheezing or worse from just a 30th of a single peanut, sometimes even less.”Until now, all doctors could advise was to read food labels and avoid anything that might contain unknown peanuts. Decades ago, attempts at shots were believed too risky for food allergies.
HOW IT WORKS: Doctors prescribe a miniscule Palforzia powder as starting dose, stored in a capsule, is mixed into any unheated food, such as Nichols’ favorite fruit smoothies. Patients take the first dose in a doctor’s office, in case of the bad allergic reaction.
In every few weeks, the dose increased until after about six months, they’re taking the equivalent of about one peanut. In a study of nearly 500 children, two-thirds who received Palforzia could eat the equivalent of two peanuts — and some can even three or four — compared to just 4% of patients given a mannequin drug.
THE WARNINGS: Palforzia users still must carry their salvage medicine, such as EpiPens, in order to treat severe allergic reactions. Most experience at least mild side effects, such as hives or stomachaches, and concerning 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 the patients treated in the Palforzia study, almost three times the number in the placebo group and prompting debate about the drug’s usefulness.
OTHER ALLERGY TREATMENTS IN THE PIPELINE ARE:
- DBV Technologies’ Viaskin is a daily patch that contains small amounts of the peanut protein absorbed through the skin, in hopes of less side effects.
- Allergen drops under the tongue are in the early-stage testing but demonstrate promise in a recent study from the University of North Carolina, Chapel Hill.
- Shots to block allergic reactions deliver antibodies that pack down the inflammatory cascade that follows accidental exposure. A Stanford University pilot study suggested that a single shot could block a peanut reaction for two to six weeks. https://fda.einnews.com/article/508616144?lcf=8DWPqPuUsDVNDakfEIxsCA%3D%3D