The Food and Drug Administration (FDA) has an approach for the expanded use of Omalizumab (Xolair), to address allergic reactions, including anaphylaxis, stemming from accidental exposure to various foods
The research supported by the National Institutes of Health (NIH) highlights the role of research in shaping pivotal advances in healthcare, as Omalzumab may be able to make life easier for those with food allergies.
Omalizumab is now being used to treat food allergies
Omalizumab, initially approved for the treatment of moderate-to-severe persistent allergic asthma, has now received FDA clearance for use in both adults and children aged one year and older with food allergies.
Individuals receiving Omalizumab must still avoid foods which they are allergic to, as this medication does not eliminate the need for allergen avoidance.
The FDA’s decision is based on data from a Phase 3 clinical trial named OUtMATCH (Omalizumab as Monotherapy and as Adjunct Therapy to Multi-Allergen OIT in Food Allergic Children and Adults), sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), a division of NIH.
Addressing food allergies
This trial, conducted by investigators within the NIAID-funded Consortium for Food Allergy Research, represents a collaborative effort aimed at addressing the challenges associated with food allergies.
The analysis of the OUtMATCH trial has provided promising insights into the efficacy and safety of Omalizumab in managing food allergies. Findings from the trial’s initial stage will be presented at the upcoming American Academy of Allergy, Asthma & Immunology Annual Meeting in Washington, D.C.
Omalizumab helping those with food allergies
The abstract outlining the final results of the trial was recently published online in the Journal of Allergy and Clinical Immunology on February 5, 2024, offering a glimpse into the potential impact of Omalizumab in revolutionising the management of food allergies.
The success of the OUtMATCH trial is made possible through the collaborative efforts of NIAID, with key industry partners, including Genentech, a member of the Roche Group, and Novartis Pharmaceuticals Corporation.
These partnerships underline the importance of public-private collaboration in driving innovation and accelerating the translation of scientific discoveries into solutions that benefit patients worldwide.
