FDA approves first drug for treatment of peanut allergy for children

USA Peanut allergy, a condition in which the body’s immune system mistakenly identifies even small amounts of peanut as harmful, is known to affect approximately 1 million children in the United States.

Out of these children, only 1 out of 5 will outgrow their allergy. A solution to this life-threatening protein has now come to this group of consumers for the first time.

The US Food and Drug Administration approved a new drug, Palforzia, to mitigate allergic reactions, including anaphylaxis, that may occur with accidental exposure to peanuts.

Palforzia is a powder that is manufactured from peanuts and packaged in pull-apart color-coded capsules for Dose Escalation and Up-Dosing, and in a sachet for maintenance treatment.

The powder is emptied from the capsules or sachet and mixed with a small amount of semisolid food – such as applesauce, yogurt, or pudding – that the patient then consumes.

Following the approval, Palforzia may be initiated in individuals ages 4 through 17 years with a confirmed diagnosis of peanut allergy. However, the treatment requires peanut allergic consumers to avoid peanuts in their diets.

“Because there is no cure, allergic individuals must strictly avoid exposure to prevent severe and potentially life-threatening reactions,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research.

“Even with strict avoidance, inadvertent exposures can and do occur. 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.”

Peanuts are the most common food allergen in the US and their allergic reactions are unpredictable in occurrence and in how they present, with some individuals experiencing severe reactions from even trace amounts.

Physical symptoms can develop within seconds of exposure and may include skin reactions (e.g., hives, redness or swelling), digestive discomfort, or more dangerous reactions, such as constriction of the throat and airways, and loss of adequate blood flow to vital organs of the body.

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Antihistamines and epinephrine can be used to treat allergic reactions, but severe reactions can be fatal even with appropriate, prompt treatment.

FDA said that Palforzia cannot be used for the emergency treatment of allergic reactions, including anaphylaxis.

The drug was assessed for effectiveness and safety. According to the regulator, the effectiveness of Palforzia is supported by a randomized, double-blind, placebo-controlled study conducted in the US, Canada and Europe in approximately 500 peanut-allergic individuals.

The results showed that 67.2% of Palforzia recipients tolerated a 600 mg dose of peanut protein in the challenge, compared to 4.0% of placebo recipients.

Palforzia will only be available through specially certified healthcare providers, health care settings, and pharmacies to patients who are enrolled in the REMS program.

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