Tami McGraw once faced life-threatening allergic reactions to red meat, to the point where even cooking fumes could trigger anaphylaxis. Her condition was so severe that she couldn’t cook for her family or enjoy social gatherings. The turning point came when her allergist prescribed Xolair, a drug initially approved for asthma. Miraculously, McGraw’s red meat allergy symptoms diminished, allowing her to live a more normal life without constant fear.
Xolair, which has been on the market since 2003 for asthma, received official approval for food allergies earlier this year. This development is significant for the millions of Americans with severe food allergies, providing a new line of defense against accidental exposures. Although Xolair is not a cure, it offers substantial protection and relief.
The drug works by targeting IgE molecules, which play a key role in allergic reactions. Despite its potential, Xolair’s path to approval for food allergies was fraught with challenges. A similar drug was shelved in 2004 due to a legal dispute, and Xolair’s clinical trials for peanut allergies faced setbacks in 2006 due to safety concerns during testing. However, promising preliminary results continued to support Xolair’s potential.
In 2014, Xolair was approved for idiopathic chronic hives, a condition often associated with high levels of IgE. This development led to a situation where Xolair was available for patients with multiple conditions but remained out of reach for those with only food allergies, due to high costs and limited insurance coverage.
A breakthrough came in 2019 with the OUtMATCH trial, a large-scale study funded by the National Institute of Allergy and Infectious Diseases and Xolair’s manufacturers. The trial demonstrated that after 16 weeks of Xolair treatment, two-thirds of participants with peanut and other food allergies could tolerate significantly more of their allergens. This success led to Xolair’s approval for food allergies by the FDA.
Xolair offers a practical advantage over oral immunotherapy, which is food-specific and requires a gradual buildup of tolerance. Xolair can treat multiple food allergies simultaneously and may be used in conjunction with oral immunotherapy to enhance safety and effectiveness. Current research is exploring whether Xolair can be combined with oral treatments to improve outcomes further.
While Xolair represents a major advancement, not all patients respond to the drug, and identifying who will benefit remains a key area of study. For many, however, Xolair is a game-changer, providing a new level of freedom and safety in managing severe food allergies.
“It’s a complete life-changer,” says Robert Wood, a pediatric allergist at Johns Hopkins who co-led the pivotal study. Despite the lengthy process to reach this point, Wood acknowledges the progress made and the hope it brings to countless individuals living with severe food allergies.
