Posts tagged with "Food and Drug Administrtion"

FDA approves first-ever drug for childhood peanut allergies

February 4, 2020

In trailblazing advancment in the fight against food allergies, the Food and Drug Administration has approved the first treatment for children with peanut allergies, NBC News reports.

The peanut allergy is a nightmare for parents, who must protect severely sensitive children from even the smell of a peanut, at home, at school, at camp+-everywhere. Indeed, The FDA acknowledges that peanut allergies are unpredictable and severe reactions can occur from even the smallest trace of peanuts.

“Peanut allergy affects approximately one million children in the United States—and only one out of five [20%] of these children will outgrow their allergy,” said Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research in a news release. “Because there is no cure, allergic individuals must strictly avoid exposure to prevent severe and potentially life-threatening reactions.”

The drug, called Palforzia, is not a cure, NBC News reports, but still marks a step forward in reducing allergic reactions for kids ages 4 through 17, who already have been diagnosed with peanut allergies.

Marks noted that even when avoiding peanuts, inadvertent exposure can still happen and that’s what this drug aims to treat. He explained, “When used in conjunction with peanut avoidance, Palforzia provides an FDA-approved treatment option to help reduce the risk of these allergic reactions in children with peanut allergy.”

The Palforzia pill is administered in three phases and is taken over time, but cannot be used in an emergency situation in the way that a treatment like an EpiPen is used.

The first phase, called initial dose escalation, is consumed on a single day under the supervision of a medical professional; while up-dosing, the second phase, takes place over several months and involves 11 increased dose levels. The first dose in up-dosing would be given under a medical professional’s supervision as well, just to manage any potential severe allergic reactions. After that, the drug can be taken at home, as long as everything goes smoothly. Once the 11 doses in the second phase are completed, the third and final maintenance dose would then be administered daily.

Research contact: @NBCNews