The U.S. Food and Drug Administration (FDA) has approved the first treatment for peanut allergies in children, much to the relief of parents everywhere.
The new drug, Palforzia, can help mitigate the allergic reactions, including anaphylaxis, that occur when children are accidentally exposed to peanuts. Palforzia has been approved for use in children 4 to 17 years old.
Peanut allergies affect approximately 1 million children in the U.S., but only about 20 percent of these children will outgrow their allergy. Parents whose children have peanut allergies know how quickly reactions can present themselves when kids are exposed to even trace amounts of peanuts.
It’s important to note that taking Palforzia isn’t a cure-all. It does not dilute the need to avoid peanuts and it even carries some risk of triggering the same allergy reactions it is trying to treat, including anaphylaxis.
“Because there is no cure, allergic individuals must strictly avoid exposure to prevent severe and potentially life-threatening reactions,” Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research, said in a statement. “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.”
Palforzia is a powder designed to be mixed in with food, such as applesauce, yogurt, or pudding. Treatment is divided into three phases: Initial dose escalation, up-dosing, and maintenance. Dr. Jayson Dallas, CEO of Aimmune Therapeutics, the biopharmaceutical company that developed the treatment, said that initial treatment is administered in very small doses and gradually increased over time until the body develops the “ability to no longer recognize peanut as foreign.”
That said, the drug is only intended to reduce the severity of reactions, not to be used for emergency treatment. “What we are trying to achieve here is the ability for children to be protected from that accidental exposure that may happen in the community,” Dr. Dallas explained. Studies found that after 6 months in the maintenance phase of dosing, 67.2 percent of Palforzia recipients had only a mild allergic response to 600 mg of peanut protein, compared to 4 percent of placebo recipients.
To mitigate the risk of anaphylaxis associated with taking Palforzia, the FDA is requiring a Risk Evaluation and Mitigation Strategy (REMS), a program that screens patients prior to taking the medication. As a result, Palforzia will only be available through specially certified healthcare providers and pharmacies to patients enrolled in the REMS program. As part of the REMS program, the initial dose and the first dose in each up-dosing level must be administered in a healthcare setting, where severe reactions can be detected and immediately managed.
Palforzia is the first in what is expected to be a new crop of food allergy medications pending FDA approval.
