FDA ap­proves first treat­ment for kids with peanut al­ler­gies

Chicago Tribune (Sunday) - - NATION & WORLD - By Lau­ran Neer­gaard

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 chil­dren’s and teens’ bod­ies to bet­ter tol­er­ate peanut so that an ac­ci­den­tal bite is less likely to cause a se­ri­ous re­ac­tion, or 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.

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.”

Aim­mune ex­ec­u­tives set the treat­ment’s list price at $890 a month, but how much pa­tients will pay de­pends on their in­sur­ance.

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, 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.

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.

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.


Al­though ap­proved by the FDA, Pal­forzia still can cause side ef­fects, in­clud­ing oc­ca­sional se­vere al­ler­gic re­ac­tions.

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