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Dining out, eating in a school cafeteria or even flying can be scary if you’re allergic to peanuts, milk, eggs and other foods. But sufferers can now breathe a sigh of relief.
The U.S. Food and Drug Administration approved the first therapy to lessen severe and life-threatening reactions in adults and children who are accidentally exposed to the foods.
“This will make a big difference in people’s everyday lives,” said Dr. Robert Wood, director of the Eudowood Division of Allergy, Immunology, and Rheumatology at Johns Hopkins Children’s Center who led studies underlying the drug approval.
“The advantage of this approach is that most of our patients are not just allergic to one food,” he said. “This treatment works irrespective of the food. And some allergens are much harder to avoid than others.”
The search for a treatment for food allergies has been underway for years. Wood said the new drug, an injection already used to treat asthma and other conditions, was an obvious choice to investigate.
He calls approval of omalizumab an important step to prevent the worst reactions to common allergens, which also include wheat, cashews, hazelnuts and walnuts.
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That’s significant because about 6% of American adults have a food allergy, according to the U.S. Centers for Disease Control and Prevention. Hopkins researchers say the numbers are closer to 8% of children and 10% of adults with at least one food allergy, and up to 86% of them are allergic to more than one food.
The drug will be marketed under the brand name Xolair by the Washington-based pharmaceutical company Genentech Inc. FDA approval generally means insurance companies will cover the cost, which is $3,000 to $6,000 a month for Xolair. Patients will need regular maintenance injections.
“It’s like Zyrtec for allergies,” Wood said. “It only works while you’re on it.”
Patients will, however, still have to avoid the foods because it’s unlikely to prevent reactions when large amounts are consumed. In studies, some could eat 2½ peanuts and some could eat a couple dozen. Doctors will advise patients to continue carrying EpiPens with a dose of epinephrine for emergencies.
For some, the drug ‘will change everything’
Niko Diaz, a 17-year-old who plans to begin taking Xolair, said he can’t wait. He was diagnosed with a peanut allergy at 9 months old and diagnosed with more food allergies over the years. Even though he won’t be free to eat anything he likes, the drug still “will change everything,” he said.
He’s always had to eat at home, bring food to visit with friends or skip events or traveling altogether out of fear of a severe allergic reaction.
His mother, Elissa Lee Koljonen, said Niko never met his grandfather in Hong Kong because she was too fearful about feeding him along the way — a big disappointment on top of constant smaller ones. A couple of weeks ago, Niko was with friend who decided to stop for food somewhere unfamiliar. Niko said he “was hungry but sat with a bottle of water.”
“Now I don’t have to follow him to college to make sure he’s OK,” Koljonen said, only half joking.
Wood, Niko’s doctor, has helped them follow his and other food allergy research over the years, which has been another layer of uncertainty. Niko was able to overcome an allergy to eggs and developed some tolerance of peanuts only to see it wane. He’s currently in a trial for another drug. They say they are grateful Wood kept at the research for so many years.
“People may say this this isn’t all that important,” Niko said. “But the idea of my life being a whole lot more comfortable, it’s huge.”
Wood, also a professor of pediatrics in the Johns Hopkins University School of Medicine, planned to present findings from the latest study Sunday at a conference held by the American Academy of Allergy, Asthma & Immunology. The research, funded by the National Institutes of Health, was also published Sunday in The New England Journal of Medicine.
The study involved participants who were 1 to 55 years old with allergies to peanuts and at least two other foods. Most increased their tolerance over 16 weeks. Extending injections to 40 weeks did not appear to increase tolerance. The FDA approved the drug Feb. 16 on an expedited basis, noting there was no cure for food allergies.
“While it will not eliminate food allergies or allow patients to consume food allergens freely, its repeated use will help reduce the health impact if accidental exposure occurs,” said Dr. Kelly Stone, associate director of the Division of Pulmonology, Allergy and Critical Care in the FDA’s Center for Drug Evaluation and Research.
The first treatment for multiple food allergies
Xolair is a monoclonal antibody that works by interrupting the reaction once the body begins producing antibodies called immunoglobulin E, or IgE, in response to a food or other allergen it considers an invader. Given its expense, it’s unlikely to be used to treat environmental allergies.
Wood said he plans to continue studying the drug to see if effects kick in before 16 weeks and if it works on people with the most extreme food allergies.
Dr. Jonathan A. Bernstein, president of the allergy association where Wood planned to present the research, agreed omalizumab was a good candidate to investigate for food allergies given its other uses. It was first approved by the FDA in 2003, making the path to the market for food allergies smoother.
Bernstein was not involved in the latest studies but participates in other allergy research.
There is only one other treatment for food allergies, and it’s limited to peanuts and only used in children, said Bernstein, also a professor of medicine at the University of Cincinnati Department of Internal Medicine’s Division of Immunology, Allergy Section. Palforzia is a peanut allergen powder used to build tolerance in patients.
Bernstein said doctors will need to use their clinical judgment in deciding who could benefit from the new drug. They’ll have to ensure they understand its limits. But he said he’s already used the drug to treat children since it was approved for other uses, and they report no reactions.
“Sometimes I hear from kids, ‘Will I be able to go to college?’” he said. “To them and their parents, this is a big deal.”
Meredith Cohn is a health and medicine reporter for The Baltimore Banner, covering the latest research, public health developments and other news. She has been covering the beat in Baltimore for more than two decades.
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