FDA Approves First Allergy-Reducing Drug for Food Allergens

FDA Approves First Allergy-Reducing Drug for Food Allergens
  • The FDA has approved the first drug for children and adults to help stop allergic reactions after accidental exposure to certain foods.
  • The medication, which is injected, is not meant to treat emergency situations such as anaphylaxis.
  • Experts say that this approval could have significant impacts, particularly for children and their families.

The US Food and Drug Administration (FDA) has announced that an injectable drug called XolairT can now be used to prevent allergic reactions after accidental exposure from allergy-triggering foods.

It is the first drug approved by the FDA to reduce the risk of allergic reactions from multiple foods after an accidental exposure.

Xolair, which has the generic name omalizumab, came to market in 2003 and has been previously approved to treat asthma, chronic rhinosinusitis, hives, and other conditions.

The medication helped 68% of people avoid a severe allergic reaction

In a clinical trial with 168 individuals, 68% of the participants, who received Xolair, were able to tolerate what amounted to 2.5 peanuts worth of allergen without having a significant allergic reaction.

The medication is approved for people over the age of one.

Dr. Daniel S. Ganjian, a pediatrician at Providence St John’s, says that this is a significant development for those facing food allergies.

Ganjian likens the medication to “a sponge” that prevents the Immunoglobulin E or IgE protein from reaching its receptor and causing an allergic reaction.

IgE-mediated foods include milk, fish, soy, and tree nuts. The study used to support this new use for Xolair also tested against cashews, milk, and eggs.

“We don’t have to just resign to eventually having to deal with allergies for the rest of our life and being scared for our kids when they go to their friend’s house. [Having to ask,] ‘What’s in the cake? What are they going to eat?’ So, this is a good thing,” Ganjian said.

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The medication is designed to help people who are accidentally exposed to an allergen but it does not cure a person of their food allergy.

In other words, Xolair is not intended to take the place of an emergency treatment like epinephrine.

Who should take Xolair?

Dr. Daniel DiGiacomo, who works in pediatrics at K. Hovnanian Children’s Hospital and is an assistant professor at the Hackensack Meridian School of Medicine, says that whether a treatment like Xolair will be a good fit for a patient and their family depends on what their goals are.

DiGiacomo, who specializes in allergies and immunology and who worked at one of the centers with patients who were involved in the study at a previous job, says that he and his colleagues have eagerly been awaiting the results. He says that, in his practice, there are a number of stages a patient would go through before something like Xolair would be broached as a possible treatment option.

There’s a lot of other education and shared decision-making that needs to come into play,” DiGiacomo said.

This can include multiple visits, blood and skin testing, as well as educating patients about how to avoid allergens and how to use emergency treatment options for a severe reaction.

Other options to reduce allergic reactions from food

Xolair isn’t the only medication on the market that can support people who are looking to reduce their allergy risk.

Palforzia, or peanut allergen powder, is available for those aged 4-17, but it only reduces the risk of a reaction to peanuts as opposed to the broader application shown by Xolair.

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As for next steps, Ganjian says that there are further areas to explore in terms of how Xolair can support patients, areas that will require more research.

There are a lot of programs and allergists who are desensitizing the kids, and sometimes it could take a good year or two,” Ganjian said. “So allergists might start using this in conjunction with desensitization protocols to make the kid be desensitized faster and quicker. That’s something that we need to look into in the future to make that happen.”

Additionally, side effects are always a concern. The FDA notes that the medication does come with a warning for anaphylaxis and that those with “a hypersensitivity” to it should not use it.

Ganjian says that having a treatment option that can broaden protection is a positive step forward.

“When I see kids with allergies, I usually see there are multiple food allergies, there are multiple triggers. So I need something that is better, and has a broader application with more foods,” Ganjian said.

Takeaway Note

The FDA has approved a drug to help treat food allergies. In the study, 68% of people using the drug called Xolair were able to tolerate what amounted to 2.5 peanuts worth of allergen without having a significant allergic reaction.


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