Roche's Xolair reduces reactions to severe food allergies in study
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[February 26, 2024]
By Nancy Lapid
(Reuters) - Xolair, a 20-year-old asthma drug sold by Roche and
Novartis, significantly reduced allergic reactions in people with
multiple severe food allergies in a late-stage trial, researchers
reported on Sunday at a medical meeting.
Based on the results, presented at the American Academy of Allergy,
Asthma & Immunology meeting in Washington, the U.S. Food and Drug
Administration approved the drug earlier this month for adults and
children age 1 year or older for reducing allergic reactions that may
occur from accidental exposure.
Xolair, a monoclonal antibody known chemically as omalizumab, was first
approved by the FDA in 2003 for treating asthma.
People using the drug will still need to avoid foods they are allergic
to, but they can worry less about unknowingly consuming tiny bits of
those foods, said study leader Dr. Robert Wood of Johns Hopkins
Children's Center in Baltimore.
“There are a lot of patients and families for whom this will make a big
difference in their lives,” Wood said.
The U.S. Department of Agriculture estimates that food allergies affect
about 2% of U.S. adults and 4% to 8% of children. Each year, the most
severe allergic reactions result in 30,000 emergency room visits, 2,000
hospitalizations, and 150 deaths.
The trial included 177 children ages 1 to 18 and three adults, all with
severe food allergies.
At the start, participants reacted to less than 100 milligrams of peanut
protein, the equivalent of about one third of a peanut, and less than
300 mg of at least two other allergens, including milk, egg, cashew,
walnut, hazelnut and wheat.
Following treatment, 67% of participants who received omalizumab could
consume the equivalent of about four peanuts without experiencing
moderate to severe allergic reactions, compared to only 7% of patients
who received a placebo.
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The logo of Swiss drugmaker Roche is seen at its headquarters in
Basel, Switzerland January 30, 2020. REUTERS/Arnd Wiegmann/File
Photo
Some 44% of those treated with the
medicine could consume the equivalent of about 25 peanuts,
researchers reported.
Patterns were similar when patients were challenged with the other
foods.
In the Xolair group, 41% of those with cashew allergy could consume
1,000 mg without a moderate or severe reaction, compared with 3% in
the placebo group. It was 66% versus 10% for milk. In those with egg
allergies, 68% could tolerate exposure after treatment compared with
no one in the placebo group, the researchers found.
Participants received 16 to 20 weeks of treatment with Xolair or
placebo every two or four weeks, based on their weight and the
amount of allergy-related antibodies in their blood.
Following additional treatment for another 24 weeks in 38 of the
children, "most participants (showed) stable or increased challenge
thresholds," the researchers said.
The study also was published on Sunday in The New England Journal
of Medicine.
(Reporting by Nancy Lapid; Editing by Bill Berkrot)
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