STREAMING NOW: Watch Now

FDA takes major step toward approving first peanut allergy treatment

The US Food and Drug Administration's Allergenic Products Advisory Committee on Friday voted in favor of approving a...

Posted: Sep 14, 2019 8:56 AM

The US Food and Drug Administration's Allergenic Products Advisory Committee on Friday voted in favor of approving a treatment for peanut allergies in children.

The drug Palforzia is designed to minimize the incidence and severity of allergic reactions in people from ages 4 to 17 with peanut allergies.

While the advisory committee has voted in favor of the treatment, the FDA will make its final approval by January. The agency frequently follows the lead of the advisory committee. If approved, this will become the first FDA approved treatment for peanut allergy.

"We are very pleased that the FDA Allergenic Products Advisory Committee has voted in support of Palforzia," said Jayson Dallas, CEO of drug manufacturer Aimmune Therapeutics. This recommendation recognizes the urgent need for patients to have a treatment option for their potentially life-threatening allergy."

More than 3 million Americans are allergic to peanuts and tree nut allergies. The American College of Allergy, Asthma and Immunology says that more than 2.5% of American children are allergic to peanuts.

Peanut allergy is one of the most common food allergies in US children. If children who are allergic to peanuts are exposed to them, they may experience an array of symptoms including cramping, indigestion, diarrhea, shortness of breath, tightness of breath, hives and swelling.

The most severe reaction is anaphylaxis, when the entire body responds with symptoms including impaired breathing, a sudden drop in blood pressure, and fainting and dizziness. If not treated immediately, anaphylaxis can be fatal.

Current advice for people with allergies is to avoid peanuts. If exposed, people with allergies should use a drug like injectable epinephrine, commonly sold as EpiPen, or for milder reactions, antihistamines.

Palforzia works essentially by exposing children to controlled dosages of peanut protein until they've reached a maintenance level. The company says in documents filed ahead of Friday's meeting with the advisory committee that the treatment is a powder mixed once each day with certain foods like apple sauce, yogurt and pudding.

A phase 3 trial submitted as evidence in favor of the drug by the manufacturers found that 2/3 of children were able to eat the equivalent of 2 peanuts without any allergic symptoms after the course of treatment. Patients may be required to take the therapy for six months or longer.

The company said the most common adverse effects were abdominal discomfort or pain, coughing, hives, itching, nausea, throat irritation and vomiting. However, about 9% of children dosed with Palforzia during the trial had to stop the treatment because their allergic reactions were so severe.

According to Aimmune Therapeutics, the advisory committee voted in favor 7 to 2 for the effectiveness of the drug and 8 to 1 in support of its safety in its use among children as long as there were additional safeguards such as patients having a dose of injectable epinephrine on hand.

Terre Haute
Partly Cloudy
88° wxIcon
Hi: 89° Lo: 73°
Feels Like: 100°
Robinson
Partly Cloudy
87° wxIcon
Hi: 90° Lo: 72°
Feels Like: 101°
Indianapolis
Mostly Cloudy
86° wxIcon
Hi: 89° Lo: 74°
Feels Like: 94°
Rockville
Partly Cloudy
86° wxIcon
Hi: 88° Lo: 74°
Feels Like: 103°
Casey
Partly Cloudy
88° wxIcon
Hi: 88° Lo: 74°
Feels Like: 103°
Brazil
Partly Cloudy
88° wxIcon
Hi: 89° Lo: 73°
Feels Like: 100°
Marshall
Partly Cloudy
88° wxIcon
Hi: 88° Lo: 72°
Feels Like: 100°
Heat Advisory This Afternoon
WTHI Planner
WTHI Temps
WTHI Radar

WTHI Events

 

Illinois Coronavirus Cases

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

Cases: 1415572

Reported Deaths: 25853
CountyCasesDeaths
Cook56308410559
DuPage937531321
Will781251042
Lake692061027
Kane60105816
Winnebago34719524
Madison32433533
St. Clair30073526
McHenry29590299
Peoria23726346
Champaign21601158
Sangamon19672245
McLean18864194
Tazewell17508308
Rock Island15398329
Kankakee14754224
Kendall1349999
LaSalle12968254
Macon11193215
DeKalb10286122
Vermilion10247154
Adams9635128
Williamson8165138
Whiteside7249174
Boone694280
Ogle629884
Grundy605879
Clinton591993
Coles5872101
Knox5735157
Jackson546465
Henry516070
Macoupin498790
Livingston494394
Woodford492683
Stephenson488186
Franklin487879
Effingham483274
Marion4782118
Jefferson4668123
Monroe452394
Randolph432587
Lee424054
Morgan413793
Fulton410959
Logan407366
Christian394875
Bureau386187
Montgomery385274
Iroquois330168
Perry328662
Fayette326856
McDonough305751
Jersey279552
Saline272057
Douglas263736
Union250241
Lawrence245027
Shelby236138
Crawford219026
Bond213624
Cass210727
Carroll204937
Pike201453
Ford194950
Hancock194132
Clark190734
Wayne190153
Warren186750
Jo Daviess183524
Richland181740
White180626
Edgar179842
Washington169625
Moultrie168128
Mason164247
De Witt161429
Piatt156314
Johnson155416
Clay155043
Greene153534
Mercer152434
Wabash148612
Massac143740
Cumberland131119
Menard128412
Jasper116918
Marshall110819
Hamilton90316
Schuyler8147
Brown8116
Pulaski7437
Stark66425
Edwards63612
Calhoun5422
Henderson53414
Gallatin5064
Scott5051
Putnam4943
Alexander48911
Hardin39612
Pope3404
Unassigned662433
Out of IL150

Indiana Coronavirus Cases

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

Cases: 768624

Reported Deaths: 13993
CountyCasesDeaths
Marion1055891807
Lake569801031
Allen43032699
St. Joseph37344568
Hamilton37335426
Elkhart29783470
Tippecanoe23503230
Vanderburgh23240405
Porter19580327
Johnson18843392
Hendricks18089323
Madison13575347
Clark13552198
Vigo12869256
LaPorte12578225
Monroe12575178
Delaware11155198
Howard10693237
Kosciusko9792124
Hancock8761150
Bartholomew8274157
Warrick8084157
Floyd8043182
Grant7378181
Wayne7239201
Boone7211105
Morgan6924143
Marshall6345117
Dubois6283118
Cass6096112
Dearborn602178
Noble600890
Henry5958111
Jackson517277
Shelby511598
Lawrence4928127
Gibson463696
Montgomery459292
DeKalb456785
Clinton456055
Harrison454077
Huntington417882
Whitley416745
Steuben411260
Miami406073
Jasper401655
Knox388691
Putnam385762
Wabash370384
Adams353856
Ripley351971
Jefferson343487
White340154
Daviess3089100
Wells304081
Greene295185
Decatur292693
Fayette286564
Posey282635
Scott281058
LaGrange277772
Clay274949
Washington254637
Randolph247783
Jennings239749
Spencer238731
Fountain235850
Starke229959
Owen222959
Sullivan221643
Fulton208945
Jay203032
Carroll197722
Orange191756
Perry189939
Vermillion181144
Rush177627
Tipton173347
Franklin172535
Parke155916
Pike142534
Blackford138032
Pulaski123748
Newton123336
Benton109715
Brown106243
Crawford105816
Martin92515
Warren87915
Switzerland8378
Union73610
Ohio58411
Unassigned0429