FDA Approves Palforzia, First Peanut Allergy Treatment Using “Immunotherapy”

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FDA Approves Palforzia, First Peanut Allergy Treatment Using “Immunotherapy”

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A panel of experts at the U.S. Food and Drug Administration was set to measure the pros and cons about this new drug that biotech company Aimmune Therapeutics created was approved by the FDA to prevent peanut allergies on Monday Sept. 16, 2019, but on Friday, Oct. 4, 2019, FDA approved the drug 7-2. 

Palforzia, is a capsule and in it is a pharmaceutical-grade dose of peanut protein that could help roughly 1.2 million children and teens in the United States alone to potentially avoid having to deal with a life-threatening peanut allergy. When a person has peanut allergies they can’t consume anything that has been around peanuts or peanut products, according to Aimmune Therapeutics. 

For peanut allergies sufferer , 13-year old Paul Jakobsen, something as simple as going to a sporting event can be life threatening, Jakobsen’s mother, Paola Luptak, stated “Going to a sporting event, especially a baseball game, with a child with a peanut allergy — you have to clear the area and then tell people ‘please don’t eat your peanuts or throw your shells.” 

Many food products are produced in factories where peanuts are used in the production of other food products causing frequent contamination. Many are surprised to learn that “peanut is the most likely food to cause anaphylaxis and death,” according to slhd.nsw.

 The peanut powder is acting as  “exposure therapy”, a psychological treatment made to help people overcome their fears according to  apa.org and webmd.com.  Dual-allergen exposure hypothesis is “the theory that exposure to food allergens through th skin can lead to allergy, while consumption of these foods at an early age may actually result in tolerance,” and depending on the “balance of these exposures, either tolerance or allergy will “win,” states the source.

  Side affects have been reported, including  allergic reactions and a need for epinephrine pen(epipen) injections, the Washington Post reported. 

Even though no one is calling Palforzia, a cure for peanut allergy, it is hoped that the drug might help ease peanut allergy concerns and let people with the allergy have small amounts of peanuts. But for now, patients still need to carry devices that treat allergic reactions.

As always, doctors, and entrepreneurs, need to test products before putting them out to the public. So in the FDA (U.S. Food and Drug Administration) they had a clinical trial. This trial involved 551 people, 496 of them were children. A tenth of those people dropped out due to side effects like allergic reactions, such as  abdominal pain or vomiting, read the post. Then fourteen percent who did have an allergic reaction needed to use an epinephrine pen (Epipen) to ease that reaction, twice as many were patients that received a “dummy”or  placebo pill.

On the bright side, in one clinical trial children who took the drug Palforzia for a year were able to tolerate the equivalent of two peanuts,  read the post.  The pill Palforzia is“a little bittersweet for everybody. Everyone’s happy to see something happening, and yet it’s not what we asked for from Santa Claus,” said Marcus Shaker, a pediatric allergist at Dartmouth’s Geisel School of Medicine.

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