Photo: Federica Narancio/AP
The U.S. Food and Drug Administration has approved the first drug for the treatment of life-threatening peanut allergy that affects more than one million American children.
The new drug, Palforzia, does not cure allergy sufferers, but it helps increase their tolerance to small amounts of peanuts to lessen the risk of a reaction to accidental exposure.
“Peanut allergy affects approximately 1 million children in the U.S., and only 1 out of 5 of these children will outgrow their allergy," said Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research. "Because there is no cure, allergic individuals must strictly avoid exposure to prevent severe and potentially life-threatening reactions.”
The FDA said Friday that Palforzia may be used for people ages 4 to 17 with a confirmed diagnosis of the allergy. It warns that patients using it must continue avoiding peanuts in their diet.
When used in conjunction with peanut avoidance, Marks said, Palforzia "provides an FDA-approved treatment option to help reduce the risk of these allergic reactions."
“It’s been a life-changer,” said Nina Nichols, 18, of Washington, whose first encounter with peanuts as a toddler – a peanut butter cracker shared by a friend – sent her to the emergency room. She entered a Palforzia research study as a teen and calls it “a security blanket.”
Peanut allergy is the most common food allergy among children. It is also among the most dangerous, sending 1 in 4 affected children to the emergency rooms every year.
It is most commonly associated with anaphylaxis, a sudden and potentially deadly condition that requires immediate attention and treatment, according to the American College of Allergy, Asthma, and Immunology.
“For so long, we had nothing to offer these patients,” said Dr. Pamela Guerrerio of the National Institutes of Health, which funded much of the research that led to food allergy therapies. “We finally have a treatment. That’s a big step.”
The asthma and immunology college says a 2017 study found that peanut allergy in children had increased 21% since 2010 and that nearly 2.5% of U.S. children may have it.
Patients ingest Palforzia, which is a powder made from peanuts, by mixing it with small amounts of semisolid food like applesauce, yogurt or pudding.
The FDA says the treatment is not for everyone and can cause its own side effects, including occasional severe allergic reactions.
Those can develop quickly, sometimes within seconds, ranging from hives, redness or swelling of the skin to digestive discomfort to such dangerous reactions as constriction of the throat and airways and loss of blood flow to vital organs.
Antihistamines and epinephrine can be used to treat some allergic reactions, the FDA says, but it notes that Palforzia cannot be used for emergency treatment.
The FDA says the drug, manufactured by Aimmune Therapeutics, will be available only through specially certified health care providers, health care settings, and pharmacies to patients who are enrolled in the Risk Evaluation and Mitigation Strategy (REMS) program.
Aimmune executives said Friday that they are hopeful that doctors can begin prescribing the treatment in “a matter of weeks.” They say the treatment's list price will be $890 a month, but the cost to patients will depend on their insurance.