Life with food allergies can be stressful and scary, particularly if you’re the parent or caregiver of a young child with a serious allergy. That’s why families and medical providers in the food allergy space are rejoicing after the U.S. Food and Drug Administration (FDA) just approved Xolair, the first medication to treat severe food allergies in kids and adults.
“This is huge for families with food allergies because, up until now, not many treatments are FDA-approved for lessening severity of food allergies, which can be life threatening,” says Dr. Purvi Parikh, a New York-based allergist and immunologist with the Allergy & Asthma Network.
Here’s what you need to know about the new medication, including how it works, where to get it and what this means for the future of medical care for adults and kids with severe food allergies.
What is Xolair, and which food allergies does it treat?
Xolair, the brand name of the drug omalizumab, is an injection given every two to four weeks to help reduce the potential for severe allergic reactions in the event of an accidental exposure. The drug is approved for use in adults and kids as young as 1 year who are allergic to various foods including:
- Milk
- Eggs
- Peanuts
- Cashews
- Walnuts
- Hazelnuts
Xolair was previously approved by the FDA to treat other conditions, including certain kinds of asthma, chronic hives and chronic inflammatory sinus disease. Its approval as a food allergy treatment is based on the results of the OUtMATCH clinical trial, which was sponsored by the National Institutes of Health. During the trial, 68% of peanut-allergic patients ages 1-55 who took Xolair for at least 16 weeks were able to consume small amounts of peanuts without severe allergy symptoms. Similar results were seen in:
- 67% of participants allergic to eggs
- 66% of participants allergic to milk
- 42% of participants allergic to cashews
Xolair works by binding to immunoglobulin E (IgE), the type of antibody that triggers allergic reactions, and preventing those antibodies from attaching to receptors in the body. According to Xolair manufacturer Genentech, there are 160 different foods that can cause IgE-related food allergies, and about 3.4 million children and 13.6 million U.S. adults have been diagnosed with food allergies. A doctor or allergist can help you determine if specific food allergies can be treated with the medication.
Does Xolair cure food allergies?
Xolair does not cure food allergies, and it cannot be used as an emergency treatment during an allergic reaction, the FDA warns. It’s meant to be a protective measure to lessen the chance of a reaction following accidental exposure to certain foods.
“You still need to carry an EpiPen [Epinephrine shot] and avoid foods you are allergic to.”
— Dr. Purvi Parikh, allergist and immunologist
“It’s an added layer of protection should you come into contact with a food allergen, so you won’t have as severe of an allergic reaction,” Parikh explains. “You still need to carry an EpiPen [Epinephrine shot] and avoid foods you are allergic to.”
What are the side effects of Xolair?
The most common side effects of Xolair include fever and injection site reactions, such as pain and swelling, says Dr. Ahmar Iqbal, an executive medical director at Genentech who co-authored the OUtMATCH study. Further, he adds, “no patients discontinued [the trial] due to adverse events.”
Some less common potential side effects of Xolair may include:
- Joint pain.
- Rash.
- Headache.
- Dry throat.
- Congestion.
- Body aches or pain.
Xolair also comes with a warning that the medication itself can trigger anaphylaxis; however, this reaction is extremely rare. A doctor can help to determine your individual risk. “Xolair has been on the market for over 20 years and has a very safe side effect profile,” Parikh adds. “As with any injectable med, there is a risk of a severe allergic reaction, but the majority of patients have no issue and tolerate it very well.”
When will Xolair be available?
Xolair is available now, and can be prescribed by any doctor, pediatrician or allergist. Additionally, patients seeking the medication will need to check with their insurance company to see if it is covered. The cost of the medication without insurance can range from $2,900 a month for children and $5,000 a month for adults, according to the Associated Press.
The bottom line on Xolair
Xolair is not a cure for food allergies, but its approval represents a major step forward for allergy patients of all ages.
“No matter how vigilant people with food allergies can be to avoid the foods they’re allergic to, the possibility for an accidental exposure is always there,” says Dr. Larry Tsai, the global head of respiratory, allergy and infectious disease product development at Genentech and father to a child with multiple food allergies. “For the first time, people with one or more food allergies have a treatment option with Xolair that can help reduce allergic reactions that may occur with an accidental exposure.”
Xolair can help prevent severe reactions to some of the most common food allergens, such as milk, eggs and certain nuts. Having this treatment option could potentially save lives. Hopefully Xolair’s approval will lead to even more research and treatment options for those living with food allergies.
