Early data from an ongoing clinical trial find an injectable asthma medication that could help curb food-related allergic reactions in children.
If studies continue to show promising results, experts hope the injection could eventually win FDA approval as a pediatric allergy treatment.
Last week, drugmakers Genentech and Novartis announced that the FDA would prioritize reviewing its application for use of omalizumab, an allergy-induced asthma drug, in cases of accidental exposure to food such as peanuts, eggs or milk.
The small study, which needs more research before possible FDA approval, combined with previous research shows how an alternative use of the drug, marketed as Xolair, could potentially help prevent allergic reactions in people with multiple food allergies, particularly anaphylaxis.
The federally funded study, supported by the National Institute of Allergy and Infectious Diseases, is scheduled to be completed in 2026.
“Despite the significant and growing health burden caused by food allergies, treatment progress has been limited,” Dr. Levi Garraway, Genentech’s chief medical officer and director of global product development, said in a press release. “We are proud to partner with the National Institutes of Health and leading research institutions on this groundbreaking study. The FDA’s Priority Review designation recognizes the unmet need for these patients, and we hope to make Xolair available to as many people living with food allergies in the United States as possible.”
The results of the study, which looked at 165 children and adolescents, regardless of the severity of reactions such as hives or anaphylaxis, showed that those receiving Xolair were able to eat more of the foods they are sensitive to without causing an allergic reaction. participants who received a placebo.
Although preliminary data show the potential of this drug in this off-label application, there is not yet enough evidence to determine how much of an effect it might have in people with food allergies.
A Genentech spokesperson told ABC News that the FDA is expected to make a decision on approval in the first quarter of 2024. And if approved, Xolair would be the first drug to reduce allergic reactions after accidental exposure to multiple foods.
Dr. Larry Tsai, Genentech’s global director of respiratory, allergy and infectious disease product development, explained to “Good Morning America” that because food allergies hit close to him, this research feels like a step in the right direction for treatment. options.
“Although I am a doctor, I am also the parent of a child with severe food allergies,” she said in an emailed statement. “I am all too familiar with the constant worry and fear that my child will be accidentally exposed at school or at a friend’s house. For the approximately 17 million children with food allergies, the current standard of care is to have children avoid the foods they are allergic to and learn to recognize and treat symptoms when exposed to an allergen.”
Despite careful monitoring, he added, “accidental exposure is difficult to prevent and there is a significant need for new treatment options for those with food allergies.”
“The positive results of the OUTMATCH trial take us one step closer to providing a new treatment option for children and adults with food allergies,” continued Dr. Tsai, who also has a food allergy herself.
Updates to the study on the Centers for Disease Control and Prevention website do not say how much more participants were able to consume without having an allergic reaction.
The drug, marketed as Xolair, has been on the market since 2003 and helps treat chronic urticaria and chronic rhinosinusitis with nasal polyps – an inflammatory disease of the sinuses.
People who take Xolair for allergic asthma typically take the drug for about 10 months, and while the price varies by indication and dose, the cost is about $3,663 a month. This price also varies according to the frequency and the person’s weight and serum IgE levels.
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