The FDA Just Approved the First Drug for Children with Peanut Allergies—Here's What You Need to Know
The number of U.S. children living with a peanut allergy increased by 21% from 2010 to 2017, with approximately 1.2 million cases—and counting. Peanuts are considered one of the top eight food allergens and are commonly associated with anaphylaxis, a sudden and potentially deadly condition that requires immediate treatment. Children living with this allergy have long been told to avoid peanuts and peanut products—and even products produced in the same facility as peanuts, depending on the severity of the allergy. Now, for the first time ever, they will also be able to receive a drug for treatment: it's called Palforzia.
Children who suffer anaphylaxis have typically been treated with epinephrine (like an EpiPen) or antihistamines (like Benadryl), but Palforzia is the first drug approved by the FDA that will not only help mitigate allergic reactions but also reduce the risk of experiencing them. Some of these allergic reactions to peanuts can include hives or redness of the skin, digestive issues and wheezing, as well as anaphylaxis. Palforzia can't be used as an emergency treatment for anaphylaxis; that is, it does not replace epinephrine.
We asked Dr. Purvi Parikh, an allergist with Allergy & Asthma Network, to give us further information on the impact Palforzia could have on those living with a peanut allergy. Here's what you need to know:
What Is Palforzia, and How Does It Work?
Palforzia is a powder made from peanuts that is packaged in capsules or sachets depending on the phase a patient is currently undergoing. The powder can be mixed in with a semi-solid food of one's choice—like yogurt or applesauce—served cold or at room temperature.
Children prescribed Palforzia will undergo three phases that occur over several months. The first phase, Initial Dose Escalation, is given on a single day and is followed by an Up-Dosing phase that increases the child's intake in 11 levels over a period of months. The first dose of each Up-Dosing level is administered by a health care professional or in a health care setting in order to manage any potentially severe allergic reactions.
If the patient responds well to all of these levels, they can enter the Maintenance phase, which requires the ingestion of the same amount of Palforzia each day. It's important to note that the patient should still avoid peanuts or peanut products during the first two levels and throughout Maintenance unless they outgrow the allergy.
"Peanut allergy affects approximately 1 million children in the U.S. and only 1 out of 5 of these children will outgrow their allergy. 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, in a press release. "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."
Related: Nut-Free Recipes
How Could Palforzia Have an Impact on Those with Peanut Allergies?
"It could have a large impact, because currently besides avoidance of the food, there is not much we can do," Parikh says. "While this is not a cure, it does help lessen the chance of a severe or life threatening reaction from accidental exposure which would be a huge relief for these patients."
Potential Side Effects of Palforzia
The FDA approved this drug after success was found in a randomized, double-blind, placebo-controlled study conducted in the U.S., Europe and Canada. The most commonly reported side effects during this study 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. Those taking this drug are encouraged to continue to keep epinephrine in a convenient location at all times due to the risk of anaphylaxis.
Can One Take Palforzia After Age 17—and Should Anyone Avoid Taking It?
Palforzia is safe to continue to take once the child enters adulthood. Those with uncontrolled asthma should not be prescribed Palforzia.
"This not a one size fits all and the appropriate patient needs to be chosen," says Parikh. "All patients need to be educated and fully informed before starting treatment. Every patient will have a unique risk tolerance level prior to treatment. Thus, you need to discuss pros and cons with a board certified allergist who is familiar with your history and the medication."
Parikh also notes cost may be an inhibitor for some.
Where Can I Find Palforzia?
This drug will only be available through specially certified health care providers, health care settings and pharmacies to patients enrolled in a Risk Evaluation and Management Strategy program required by the FDA. Health care providers who can prescribe Palforzia are educated on the risk of anaphylaxis associated with its use. Patients and their parents or caregivers will be counseled on the need for the patients to have an EpiPen available at all times for immediate use, the need for continued dietary peanut avoidance and how to recognize the signs and symptoms of anaphylaxis.
The Bottom Line
Palforzia is an exciting new drug that has the potential to not only help mitigate allergic reactions caused by peanut allergies but also reduce the risk of experiencing them at all. For those families managing peanut allergies, this could be a monumental step in their care. If you or someone you know wants to learn more about this new drug, speak to your health care provider or pharmacist for additional information.