Early data from an ongoing clinical trial finds an injectable asthma drug may help prevent food-related allergic reactions in children.
If the studies continue to show good results, experts hope that the injection may eventually win FDA approval as an allergy treatment for children.
Last week, pharmaceutical developers Genentech and Novartis announced that the FDA is prioritizing review of its application for the use of Omalizumab, an allergy-induced asthma drug, in cases of accidental exposure to foods such as peanuts, eggs or milk.
The small study, which needs more research before a potential FDA approval, combined with previous research points to how the alternative use of the drug marketed as Xolair could potentially help to prevent allergic reactions in people with multiple food allergies, especially anaphylaxis.
The federally funded trial supported by the National Institute of Allergy and Infectious Diseases is scheduled to end in 2026.
“Despite the large and growing health burden from food allergies, treatment advances are limited,” said Dr. Levi Garraway, Genentech’s chief medical officer and head of Global Product Development in the 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 look forward to making Xolair is available to as many people as possible living with food allergies in the US”
Data from the trial, which looked at 165 children and adolescents — whose severity of reactions such as rashes or anaphylaxis were not included — showed that those who received Xolair ate more food that they were sensitized without triggering an allergic reaction, compared to participants who received a placebo.
Although preliminary data show potential for this drug in this off-label application, there is not yet enough evidence to determine how effective it is for people with food allergies.
A Genentech spokesperson told ABC News that the FDA is expected to make an approval decision in the first quarter of 2024. And if approved, Xolair would be the first drug to reduce allergic reactions to multiple foods following an accident. exposure.
Dr. explained Larry Tsai, VP and Global Head of Respiratory, Allergy, and Infectious Disease Product Development at Genentech, told “Good Morning America” that because food allergies are close to him, this study feels like a step in proper direction for treatment. Choices.
“While I am a physician, I am also a 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 have an accidental exposure at school or at a friend’s house. For the approximately 17 million children living with food allergies, the current standard of care treatment is that children should avoid the foods they are allergic to, and learn to recognize and treat symptoms when exposed to an allergen.”
Even with careful monitoring, he added that “accidental exposures are difficult to prevent and there is a great need for new treatment options for children with food allergies.”
“The positive results from the OUTMATCH study bring us one step closer to providing a new treatment option for children and adults affected by food allergies,” continued Dr. Tsai, who also has a food allergy.
Updates for the trial on the Centers for Disease Control and Prevention website did not list how many of the food participants were able to eat without an allergic reaction.
The drug, sold as Xolair, has been on the market since 2003 and helps treat chronic rashes as well as chronic rhinosinusitis with nasal polyps — an inflammatory sinus disease.
People who take Xolair for allergic asthma, typically take the drug for about 10 months and while the price varies based on indication and dose, the cost is about $3,663 per month. That price also varies depending on frequency as well as a person’s weight and their serum IgE levels.
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