United States: The United States Food and Drug Administration (FDA) is now allowing the use of omalizumab, and its trademarked name, Xolair, is in the leading position.
The body has acted, so last week, additional people with food allergies were added because of the results of an interim analysis of the study.
About the study
The findings revealed that the medication for asthma, i.e. Xolair, has considerably decreased severe allergic reactions among people who have multiple food allergies and have, by mistake, experienced exposure to those foods.
The study findings were published on Sunday in the New England Journal of Medicine, revealing that multiple injections of the drug during the course of several weeks have reduced the extremity of allergic reactions in some adults and children as young as one who possess an allergy to peanuts and eggs, wheats and other food items, as CNN Health reported.
Data published Sunday in the New England Journal of Medicine shows that repeated injections of the medication over the course of several weeks reduced the severity of allergic reactions in certain adults and children as young as one who is allergic to peanuts and other foods such as milk, egg, and wheat.
Xolair treats people with multiple food allergies
According to experts, by adding a variety of foods to the study, scientists could determine that Xolair has the potency to reduce allergic reactions in a person who has consumed multiple foods that they are allergic to at one time.
Dr. Sharon Chinthrajah, a senior author of the study and an associate professor at Stanford University, said, “This is an amazing step forward in our field,” and, “There’s so much fear and anxiety that goes into everyday activities for food allergy patients or parents of a food allergy patient.”
She added that Xolair provides protection to people with food allergies with protection against accidental ingestion of food, causing reactions to them. Thus, there will be anaphylaxis as a serious and life-threatening allergic reaction that needs a quick psychotherapeutic approach like intramuscular injection of epinephrine.
As CNN Health reports, the only FDA-approved other than Xolair for treatment of food allergies is Palforzia, which is an oral immunotherapy given in case of peanut allergies in children between 4 and 17 years old.
Wood added, “But the reality is that most of our patients don’t just have peanut allergy,” and, “Having something that’s really agnostic to the specific food is going to cover far more food allergy patients.”
About Xolair treatment
It was developed and marketed by Genentech and Novartis in the US and approved in 2003 for the treatment of severe cases of persistent allergic asthma.
In the case of the approval for the food-allergic people, the FDA required a phase 3 placebo-controlled trial with the “whole dataset of peanut allergic people,” as Wood says, because peanut allergy is the top most common food allergy, particularly for children.
The psychologist presented foods like peanuts, cashews, eggs, milk, walnuts, hazelnuts, and wheat, which are some of the most widespread allergens on Earth, according to her.
The source of the funding for the study was the National Institutes of Health, and the researchers’ volunteers were 180 people who had a history of at least two other food allergies apart from peanut allergy. Participants were allocated to the group that received omalizumab or just a placebo every two to four weeks and 16 to 20 weeks long.
As CNN Health reported, except for three, the rest of the participants were 17 or younger. The rest were adults aged between 19 and 26 and added Wood.
In analyzing the outcomes of the study, the researchers studied 177 participants who were 17 and younger.
Wood mentioned that before this trial, Xolair had never been studied below the age of 6 and stated, “Out of our 177, 68 were ages five or below,” as CNN Health reported.
Wood added, “To have a large group of study participants in the very youngest age group was very meaningful,” and, “We know a lot about this drug from all its years of use in asthma, but the safety of young children has not been studied, so that was an important reassuring aspect of the study.”
Moreover, the researchers noted that “The trial also has limitations,” and only three adults were included, and the cohort was mostly non-Hispanic and White, which could reduce the generalizability of the results.”
Does Xolair have negative effects?
Some people have testified that Xolair is safer than oral immunotherapy treatments in case of food allergies, as Dr. Thomas Casale, a professor of medicine and pediatrics at the University of South Florida Tampa and a past president of the American Academy of Allergy Asthma and Immunology stated, who was not part of the latest study.
Moreover, as experts mentioned, Xolair “provides as much protection or more protection” as compared to the FDA-approved Palforzia, as Casale said, as it mainly works when there is exposure of children to peanuts protein within a maintenance level.
As per the CNN Health reports, not like oral immunotherapy, Xolair is considered an anti-IgE injection, according to Wood. “IgE is an antibody that our immune system makes, and it is specifically related to developing allergy.”
As per the expert Wood, when our bodies have already produced IgE antibodies, which respond to a certain allergen, like milk or peanuts, a trigger response in terms of a full-blown allergic reaction takes place. Wood said, “The purpose of Xolair is to bind and block those IgE antibodies, preventing an allergic reaction,” as CNN Health reported.