For people with multiple food allergies, new research suggests that a drug already approved for asthma and chronic hives may protect against severe reactions to peanuts, eggs, milk and other foods.
In an early analysis of data from a clinical trial supported by the National Institute of Allergy and Infectious Diseases, 165 children and adolescents who received injections of the drug Xolair were able to eat higher doses of foods without triggered an allergic reaction, compared to those treated with placebos, said Dr. Alkis Togias, chief of the allergy, asthma and airway biology branch at NIAID.
The main advantage of this drug is that it will cover more than one food and that it has been around for almost two decades and we know its safety profile, which is quite good, Togias said.
The monoclonal antibody omalizumab, marketed as Xolair and developed by Genentech and Novartis, is already available as a treatment for asthma. The drug has been shown to reduce allergic asthma attacks and hives in clinical trials.
On December 19, NIAID and Genentech announced that the Food and Drug Administration is fast-tracking the approval of an injectable drug to be used against accidental exposure to foods.
Since the drug has FDA approval for asthma, it can now be prescribed off-label to patients, but doctors say it can be difficult to get medical centers to clear it and insurers to pay for it. a prescription for food allergies.
The monthly cost for Xolair for allergic asthma is about $3,663 and the average person with the condition takes the drug for about 10 months, according to Genentech spokeswoman Lindsey Mathias. For chronic spontaneous urticaria, the monthly cost ranges from $1,323 to $2,646, depending on the dose.
Full FDA approval of the drug as a treatment for food allergies would help with insurance issues, Togias said.
Insurance companies can still refuse even if FDA approval is granted, it’s harder for them to do so if there’s an approved indication, he said.
About 2% of adults and between 4% and 8% of children in the US have food allergies, according to the USDA. Anaphylactic shock caused by the consumption of an allergen results in 30,000 emergency room visits, 2,000 hospitalizations and 150 deaths each year.
About 40% of people with food allergies are allergic to multiple foods, Togias said.
There have been many small studies that have found the drug to be protective, but to get FDA approval there needs to be a large clinical trial.
In a trial description on clinicaltrials.gov, researchers looked for people with peanut allergies, along with two other foods that can cause adverse reactions, such as tree nuts (cashews, hazelnuts or walnuts), milk and eggs. . Participants ages 1 to 17 were enrolled, along with three adults ages 18 to 55, all with confirmed allergies to peanuts and at least two other common foods, according to the National Institutes of Health.
In the first part of the study, participants were given:
600 mg of peanut protein, which is equivalent to about two and a half peanuts.
1,000 mg of egg protein, equal to one-fifth of a raw egg.
Or 600 mg of milk protein, equivalent to about an ounce of raw milk.
Participants were also tested with a dose that combined proteins from several foods that caused allergic reactions.
Xolair’s possible approval for food allergies has been a long time coming, said Dr. Joyce Yu, an expert in pediatric allergy and immunology at Columbia University’s Vagelos College of Physicians and Surgeons.
FDA approval could potentially make life simpler for both doctors and patients, said Yu, who added that he did not use the drug off-label because it was difficult to get permission for it.
This would be a useful option for parents who feel between a rock and a hard place, Yu said.
Dr. Cosby Stone, an assistant professor of allergy and immunology at Vanderbilt University Medical Center, explained that the drug, which is a man-made antibody, works by tamping down a part of the immune system called IgE, which is released in abundance when the body mistakenly recognizes an allergen as a parasitic infection.
A drug that can make children with allergies less sensitive to common foods would be very important to children, especially children, and their parents because it is not easy to keep children away from any kind of exposure, Stone said.
There’s already evidence out there in cohort studies showing that it tends to protect people from serious reactions, Stone said. But I think everyone in our field would be glad to have evidence from a randomized controlled trial.
The FDA declined to comment on the drugs’ approval status, but NIAID and the two drugmakers recently announced that the FDA had granted priority review for Xolair.
Preliminary testing showed that Xolair significantly increased the amount of primary peanut and milk, egg and cashew nuts needed to cause an allergic reaction in children and adolescents with food allergies, Dr. Larry Tsai, global head of respiratory, allergy and infectious disease product development at Genentech, said in an email.
The full trial findings are expected to be published in a medical journal in late January or February.
FDA approval could happen in the first quarter of 2024, Togias said.
For Tsai, the test findings are personal, as she has food allergies and also has a child with severe food allergies.
I know firsthand how difficult it is to cope with this condition and live in constant fear of an accidental exposure, said Tsai.
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