- Many people with allergies and their families live in constant anxiety about exposure to allergens and often avoid eating out and other social situations.
- Xolair, the brand name for the drug omalizumab, became the first drug approved to reduce allergic reactions caused by accidental exposure to food triggers.
- One-year-old patients with allergies can take the medication by injection every two to four weeks, depending on their weight and their body’s response to the allergen.
Chicago (wagon) — For decades, asthma patients have used medications to help them breathe better. The Food and Drug Administration now agrees to use the drug to reduce severe reactions caused by food allergies.
Xolair, the brand name for the drug omalizumab, became the first drug approved to reduce allergic reactions caused by accidental exposure to food triggers. Her one-year-old patient with allergies can receive the drug by injection every two to four weeks, depending on his weight and his body’s reaction to the allergen.
Many people with allergies and their families live in constant anxiety about exposure to allergens and often avoid eating out and other social situations.
“Having this protection would be life-changing,” said Robert Wood, director of pediatric allergy at the Johns Hopkins Children’s Center.
The FDA’s decision was based on research led by Wood and funded by the National Institutes of Health. They found that with Xolair, about 68% of participants with peanut allergies were able to tolerate about 600 milligrams, or 1/2 teaspoon, of peanut protein, compared to those who received dummy shots. Approximately 6% was shown to be acceptable.
The results were similar for other allergens, including tree nuts, milk, eggs, and wheat, the study summary reported. Full results will be presented at a conference and published in a peer-reviewed journal later this month.
Wood estimates that 25% to 50% of people with food allergies, especially children and adolescents, choose to use Xolair.
Ruchi Gupta, director of Northwestern University’s Center for Food Allergy and Asthma Research, said the drug is used “off-label” to treat food allergies. She welcomed full approval of the product.
Xolair is a monoclonal antibody, a type of treatment that works by blocking the body’s natural response to allergens. First approved in 2003, it has been used to treat asthma, nasal polyps, and chronic hives. It is manufactured by the pharmaceutical companies Novartis and Roche and distributed by Genentech, a subsidiary of Roche.
“For patients with severe food allergies and their parents, this really makes a big difference,” says Sai Nimmagadda, an allergist at Lurie Children’s in Chicago.
“Every day here in Lurie, we see two or three children come in with reactions,” Nimmagadda said.
“Patients who took Xolair were able to tolerate larger amounts of food compared to a placebo. This prevented up to 40 percent of patients having allergic reactions and prevented 30,000 emergency department visits annually. will be done,” Nimmagadda said.
“This is the first known drug indicated for the prevention of food allergies,” Nimmagadda said.
It means alleviating the constant fear of accidental, life-threatening allergies.
“What we’re looking at is that patients on Xolair can tolerate up to 2.5 peanuts, up to 3.5 cashews, up to 2 teaspoons of milk, maybe a quarter teaspoon before they have a reaction. I mean, eggs,” Nimmagadda said. “So the threshold is raised a little bit. So instead of trace amounts causing an allergic reaction, you can now feel confident that an accidental exposure won’t send you to the emergency room.”
“Even if you eat the food you’re allergic to, you won’t have any allergic effects,” Nimmagadda says.
The most common side effects of Xolair are injection site reactions and fever, but the FDA also noted that the drug has been associated with joint pain, rashes, parasitic infections, malignancies, and laboratory test abnormalities. Xolair comes with a warning that the treatment itself can cause anaphylaxis and should be started in a medical setting equipped to manage reactions.
This drug is not approved for the emergency treatment of allergic reactions.
List prices for Xolair range from about $2,900 per month for children to $5,000 per month for adults, according to Genentech. The company says most insured patients typically have low out-of-pocket costs.
The Associated Press contributed to this report.
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