CHICAGO (WGN) — For decades, asthma patients have used a drug to help them breathe better. Now, the Food and Drug Administration has given the nod to use that drug to reduce serious reactions from food allergies.
Xolair, the brand name for the drug omalizumab, became the first medication approved to reduce allergic reactions caused by accidental exposure to food triggers. Patients as young as age 1 with allergies can take the drug by injection every two to four weeks, depending on their weight and their body’s response to allergens.
Many people with allergies — and their families — live with constant anxiety about exposure to allergens and often avoid dining out and other social situations.
“To have this protection is going to be life-changing,” said Dr. Robert Wood, director of the pediatric allergy division at Johns Hopkins Children’s Center.
The FDA decision is based on a study led by Wood and funded by the National Institutes of Health. It showed that Xolair allowed about 68% of participants with peanut allergies to tolerate about 600 milligrams, or about 1/2 teaspoon, of peanut protein, compared with about 6% of those who received dummy injections.
The results were similar for other allergens such as tree nuts, milk, egg and wheat, a study abstract reported. Full results are expected to be presented at a meeting and published in a peer-reviewed journal later this month.
Wood estimated that 25% to 50% of people with food allergies, particularly children and young adults, would elect to use Xolair.
The drug has been used “off-label” to treat food allergies, said Dr. Ruchi Gupta, director of the Center for Food Allergy & Asthma Research at Northwestern University. 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. It was first approved in 2003 and has been used to treat asthma, nasal polyps and chronic hives. It is produced by drugmakers Novartis and Roche and is distributed by a Roche subsidiary, Genentech.
“This really is a difference maker for patients and parents who have severe food allergies,” said Dr. Sai Nimmagadda, an allergist at Lurie Children’s Hospital in Chicago.
“Every day here at Lurie, you see two or three kids come in with a reaction,” Nimmagadda said.
“Patients on Xolair were able to tolerate higher quantities of food compared to placebo. It will prevent up to 40% of patients who have allergic reactions and 30,000 ER visits a year,” Nimmagadda said.
“It’s the first known medication with the indication to prevent food allergies,” Nimmagadda added.
That means relieving the constant fear of accidental, life-threatening allergies.
“What we’re noticing is patients who are on Xolair can tolerate up to two and a half peanuts before they have a reaction, up to three and a half cashews, up to about two teaspoons of milk and maybe up to a quarter teaspoon of egg,” Nimmagadda said. “So, it brings the threshold up a little bit. So, instead of trace amounts causing the allergic reaction, now you can feel safe you can have accidental exposures and not end up in the emergency room.”
“You don’t have the allergic effects when you ingest the food you are allergic to,” Nimmagadda said.
The most common side effects of Xolair are injection site reactions and fever, but the FDA noted the drug has also been associated with joint pain, rash, parasitic infections, malignancies and abnormal laboratory tests. Xolair comes with a warning saying the treatment itself can cause anaphylaxis and must be started in a health care setting equipped to manage the reaction.
The medication is not approved for emergency treatment of allergic reactions.
The list price for Xolair ranges from about $2,900 a month for children to $5,000 a month for adults, according to Genentech. Most insured patients typically pay less out of pocket, the company said.
The Associated Press contributed to this report.
