First Peanut Allergy Drug Gets Approved


The Food and Drug Administration recently approved the first drug for the treatment of peanut allergies in children aged four and older. Although children will still have to avoid peanuts while taking this medication. The drug aids in the case of accidental peanut exposure by decreasing the chances of a deadly allergic reaction.

Peanut allergy affects approximately 1 million children in the U.S. and only 1 out of 5 of these children will grow out of their allergy. Since there is no cure, people allergic to peanuts avoid products with peanuts to prevent severe and potentially life-threatening reactions. Allergic reactions to peanut are unpredictable in when and how they appear. Physical symptoms can develop within seconds of exposure and may include, hives, redness or swelling of the skin, digestive discomfort, constriction of the throat and airways, and loss of adequate blood flow to vital organs of the body. Antihistamines and epinephrine can be used to treat allergic reactions, but severe reactions can be fatal.

The drug, Palforzia, was approved for use in individuals aged 4 through 17 who have a confirmed diagnosis of peanut allergy. Its effectiveness is supported by a randomized, double-blind, placebo-controlled study conducted in the U.S., Canada, and Europe in approximately 500 peanut-allergic individuals. The most commonly reported side effects of Palforzia were abdominal pain, vomiting, nausea, tingling in the mouth, itching, cough, runny nose, throat irritation and tightness, hives, wheezing and shortness of breath and anaphylaxis. To mitigate the risk of anaphylaxis associated with Palforzia, the FDA is requiring a Risk Evaluation and Mitigation Strategy (REMS) with this approval, which includes elements to assure safe use. Palforzia should not be administered to those with uncontrolled asthma and will only be available through specially certified healthcare providers, health care settings, and pharmacies. Patients or their parents or caregivers must also be counseled on the need for the patients to have injectable epinephrine available for immediate use at all times and how to recognize the signs and symptoms of anaphylaxis.