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Power Over Peanut Allergies: FDA Approves Breakthrough Oral Immunotherapy

Published on February 4, 2020 in Cornerstone Blog · Last updated 3 years 3 months ago


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The drug will help minimize severe reactions to accidental exposure for many children managing peanut allergies, according to Jonathan Spergel, MD, PhD, who led the initial preclinical studies for the oral immunotherapy.

By limjr [at] (Jillian Rose Lim)

Having a peanut allergy may mean more freedom and less fear of a reaction thanks to a first-of-its-kind oral medication approved by the U.S. Food and Drug Administration. 

The approval comes after more than a decade of research conducted in part by experts in the Allergy Program at Children’s Hospital of Philadelphia. The oral immunotherapy will help minimize severe reactions to accidental exposure for many children managing peanut allergies – of which there are 1.2 million children in the U.S. – according to Jonathan Spergel, MD, PhD, who led initial preclinical studies of the medication.

“For many patients, [this medication] opens up their lives tremendously,” said Dr. Spergel, section chief of CHOP’s Food Allergy Center. “They're able to go out to dinner, or go out to a ballgame, or travel with a lot less anxiety. It gives them some level of confidence, and for many patients, it’s really opened up the door to do many things restricted to them in the past. For patients who have done well, it’s been truly life changing.”

Children and young adults ages 4 to 17 are eligible for the drug, which pharmaceutical company Aimmune Therapeutics manufactures. Previously, no treatments for peanut allergies existed, save for avoiding peanuts altogether. And despite a parent or caregiver’s best attempts to monitor what their child consumes, reactions to peanut allergies still send one in four children to the emergency room every year. 

Though the oral medication is not a cure-all, it may make peanut allergies more manageable by building resilience within the body over a period of time. By exposing patients to an increasing daily dose of peanut powder, the medication reduces the body’s reaction to peanuts. 

“When you have an allergic reaction and are exposed to the allergen, you get hives, coughing, wheezing, anaphylaxis – all the classic reactions,” Dr. Spergel said. “The idea of immunotherapy is to slowly get your body used to that reaction.” 

When developing the oral drug, researchers followed the same principle behind allergy shots, as patients receive small but increasing amounts of the allergen over time. In the case of this oral medication, a child with a peanut allergy begins taking a dose containing 300th of a peanut every day for two weeks. They then move 25 percent more (200th of a peanut), increasing the amount of exposure across several months to one whole peanut. 

“If you’re going to have a reaction, the reaction is going to be milder because you’re slowly desensitizing your body to it,” said Dr. Spergel, who is also a professor of pediatrics in the Perelman School of Medicine at the University of Pennsylvania.

In clinical trials, Dr. Spergel and his team found that they were able to get 60 to 70 percent of patients to successfully tolerate the maintenance dose – equal to one peanut – with reduced incidence and severity of reactions. About 10 percent of patients had severe anaphylactic reactions, like abdominal pain or vomiting. Another 20 percent had to stop due to gastrointestinal symptoms. It is this 30 percent that Dr. Spergel and his team hope to focus on in future research. Their goal is to truly improve the safety surrounding peanut allergies.

“When we originally started this research, we wanted to say, ‘You can eat as many peanuts as you like and not worry about it.’ But we realized patients don’t want that. Patients just want to be safe,” Dr. Spergel said. “So, our goal now is much more safety-oriented: to prevent a severe reaction so that children can go out and worry less. You still cannot eat a PB and J sandwich, but you can go to a diner and not worry that something may have touched peanuts.”  

Alongside the oral immunotherapy, researchers in the Allergy Program are also working on novel skin patches that could desensitize reactions to peanuts and milk for children with those allergies. The FDA is expected to review both patches this year. 

“Each patient is unique, and the idea of having two potential therapies [for peanut allergies] is very exciting, and it will give patients options of what to do and which is the right one for them,” Dr. Spergel said.

Learn more about the new oral immunotherapy for peanut allergies.