FDA approves first drug to treat peanut allergies in children

By Leah Asmelash, Jen Christensen and Nadia Kounang, CNN

(CNN) -- The US Food and Drug Administration approved the first drug to treat peanut allergies in children on Friday, following an advisory committee vote of approval in September.

The drug, Palforzia, can be used for children between 4 and 17 years old. It's designed to minimize the incidence and severity of a child's allergic reaction to peanuts, as even a small amount of exposure can be harmful to children with the allergy.

Children are left attempting to avoid exposure to peanuts to avoid reactions. Though that will continue to be necessary with Palforzia, the risk of a reaction will be lessened, says Dr. Peter Marks, director of the FDA's Center for Biologics Evaluation and Research, in a statement.

"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," he said.

More than 2.5% of all American children are allergic to peanuts, according to The American College of Allergy, Asthma and Immunology. It's one of the most common food allergies in the country.

For those allergic, exposure to peanuts can result in symptoms like cramping, indigestion, hives, swelling and even fainting or dizziness.


How it works


The new treatment essentially works by exposing children to controlled dosages of peanut protein until they've reached a maintenance level.

In a trial submitted by Aimmune Therapeutics, the manufacturers of the drug, two-thirds of children were able to eat the equivalent of two peanuts with no allergic symptoms after the months-long treatment. Patients may be required to take the therapy for six months or longer, and about 9% of the children dosed with the drug had to stop treatment because their allergic reactions were so severe.

Anaphylaxis can occur any time with Palforzia, but patients are at highest risk during and after initial dose escalation and the first dose of each up-dosing level; both are administered under supervision in a health care setting so providers can monitor for reactions. If a patient tolerates the first dose of an increased level, the patient can continue it daily at home. Palforzia comes in a powder form that is made from actual peanuts, and should be mixed with semi-solid food like yogurt or applesauce.

Providers will also have to counsel patients or their caregivers to have an injectable epinephrine drug with them that can be ready to be used at all times.

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