FDA approves first treatment for kids with peanut allergy

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.

Posted: Jan 31, 2020 5:54 PM
Updated: Feb 4, 2020 9:05 AM

WASHINGTON (AP) — 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 children’s and teens’ bodies to better tolerate peanut 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 like 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.

“For so long, we had nothing to offer these patients,” said Dr. Pamela Guerrerio of the National Institutes of Health, which funded much of the research that led to food allergy therapies. “We finally have a treatment. That’s a big step.”

FOOD ALLERGY IS A GROWING PROBLEM

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, with about 1 in 4 affected children winding up in the emergency room every year.

What happens: 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 single peanut, sometimes even less, said Dr. Hemant Sharma, who leads oral treatment studies at Children’s National Hospital in Washington.

Until now, all doctors could advise was to read food labels and avoid anything that might contain hidden peanuts. Decades ago, attempts at shots were deemed too risky for food allergies. Then, in 2006, researchers at Duke University and the University of Arkansas reported tantalizing signs that swallowed treatments might work instead.

HOW IT WORKS

Doctors prescribe a miniscule Palforzia starting dose. The powder, 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 a bad allergic reaction. Every few weeks, the dose is 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 three or four — compared to just 4% of patients given a dummy drug.

A few hundred allergy doctors around the country already offer their own version of the treatment, using store-bought peanut flour — or similar options for other food allergies — to customize doses for patients outside of research studies.

THE WARNINGS

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,” Sicherer said. Families and doctors together will have to decide “does it make sense for me or my child?”

OTHER OPTIONS

Other allergy treatments in the pipeline:

--DBV Technologies’ Viaskin is a daily patch that contains small amounts of peanut protein absorbed through the skin, in hopes of fewer side effects.

—Allergen drops under the tongue are in early-stage testing but showed promise in a recent study from the University of North Carolina, Chapel Hill.

—Shots to block allergic reactions deliver antibodies that tamp down the inflammatory cascade that follows accidental exposure. A Stanford University pilot study suggested a single shot could block a peanut reaction for two to six weeks.

“Palforzia is a step forward,” said Children’s National’s Sharma. “What all of us hope for that would be truly revolutionary is a treatment that’s curative, that really gets rid of the food allergy permanently.”

___

The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education. The AP is solely responsible for all content.

Terre Haute
Clear
73° wxIcon
Hi: 76° Lo: 51°
Feels Like: 73°
Robinson
Scattered Clouds
72° wxIcon
Hi: 72° Lo: 50°
Feels Like: 72°
Indianapolis
Broken Clouds
71° wxIcon
Hi: 75° Lo: 52°
Feels Like: 71°
Rockville
Scattered Clouds
68° wxIcon
Hi: 77° Lo: 50°
Feels Like: 68°
Casey
Few Clouds
72° wxIcon
Hi: 74° Lo: 51°
Feels Like: 72°
Brazil
Clear
73° wxIcon
Hi: 74° Lo: 50°
Feels Like: 73°
Marshall
Clear
73° wxIcon
Hi: 75° Lo: 50°
Feels Like: 73°
Clear & Cool
WTHI Planner
WTHI Temps
WTHI Radar

WTHI Events

 

Illinois Coronavirus Cases

(Widget updates once daily at 7 p.m. CT)

Confirmed Cases: 184522

Reported Deaths: 7723
CountyConfirmedDeaths
Cook1072474897
Lake12089440
DuPage11558510
Kane9239298
Will8650339
Winnebago3688125
St. Clair3655156
McHenry2961114
Madison222273
Kankakee168668
Rock Island160531
Champaign154719
Unassigned1347197
Peoria134135
Kendall129123
Sangamon103733
DeKalb85029
Boone73523
Jackson65019
McLean57215
LaSalle56020
Macon48923
Adams4454
Randolph4357
Coles40119
Tazewell3888
Ogle3775
Clinton34917
Williamson3415
Stephenson3186
Whiteside31316
Union30321
Grundy2825
Monroe27813
Knox2621
Iroquois2497
Vermilion2152
Henry2071
Morgan2035
Cass20211
Jefferson19217
Warren1830
Lee1482
Montgomery1477
Bureau1442
Marion1380
Macoupin1373
Franklin1320
McDonough12815
Perry1261
Effingham1161
Christian1154
Jo Daviess1131
Saline1131
Douglas1022
Woodford983
Livingston922
Pulaski910
Logan860
Jersey701
Mercer700
Clark680
Shelby601
Fayette583
Washington580
White580
Bond572
Johnson570
Moultrie550
Jasper537
Wayne501
Menard480
Piatt480
Cumberland472
Carroll463
Gallatin450
Lawrence420
Mason420
Ford411
Alexander360
Hancock341
Massac340
Wabash320
De Witt300
Crawford290
Edgar260
Fulton260
Hamilton230
Marshall210
Greene200
Hardin170
Schuyler170
Clay140
Brown130
Edwards130
Pike130
Richland130
Scott110
Henderson90
Pope80
Putnam80
Calhoun70
Stark70
Out of IL00

Indiana Coronavirus Cases

(Widget updates once daily at 8 p.m. ET)

Confirmed Cases: 68433

Reported Deaths: 2980
CountyConfirmedDeaths
Marion14863719
Lake7101271
Elkhart459777
Allen3635158
St. Joseph315479
Hamilton2513104
Cass17519
Hendricks1750105
Vanderburgh172612
Johnson1652118
Porter119539
Tippecanoe110311
Clark108145
Madison84765
LaPorte83829
Kosciusko81912
Howard81065
Bartholomew74347
Marshall74222
Floyd69444
Monroe68630
Delaware63852
Noble63728
Boone63546
Dubois62612
Hancock62337
Jackson5524
LaGrange54210
Warrick51630
Shelby51126
Grant49629
Vigo47410
Dearborn46528
Morgan42532
Henry36118
Clinton3573
White34710
Montgomery34321
Lawrence32827
Wayne3179
Decatur31432
Harrison29422
Miami2582
Scott25010
Daviess24619
Greene23934
Franklin22410
DeKalb2224
Putnam2228
Jennings21012
Jasper2082
Gibson2004
Steuben2003
Ripley1887
Perry17212
Starke1657
Orange16424
Wabash1613
Posey1580
Fayette1557
Jefferson1492
Whitley1486
Fulton1462
Carroll1452
Wells1342
Knox1310
Huntington1183
Washington1161
Spencer1143
Newton11010
Tipton1075
Randolph1034
Clay975
Jay820
Adams812
Rush794
Owen781
Sullivan761
Pulaski721
Brown701
Fountain632
Benton600
Blackford532
Ohio514
Pike460
Parke451
Switzerland430
Crawford420
Martin420
Vermillion380
Union320
Warren191
Unassigned0200