Basel, Switzerland- Roche is one step closer to gaining FDA approval for Xolair® (omalizumab). The agency accepts its supplemental Biologics License Application (sBLA) under Priority Review. The application targets the reduction of allergic reactions, including anaphylaxis, resulting from accidental exposure to one or more foods in patients aged 1 year and older with food allergies.
If approved, Xolair would be a novel treatment. Those with food allergies would need to stay away from particular allergens even while they are taking medication. The filing acceptance follows a positive interim analysis from the National Institutes of Health (NIH)-sponsored pivotal phase III OUtMATCH study. This study assesses Xolair’s effectiveness in patients allergic to peanuts and at least two other common foods.
Xolair has the potential to become the first medication to mitigate allergic reactions to multiple foods following accidental exposure. The FDA is expected to make a decision on approval in the first quarter of 2024. Limited treatment advances have constrained addressing the growing health burden of food allergies.
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“Despite the significant and growing health burden from food allergies, treatment advances have been limited,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “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 acknowledges the unmet need for these patients, and we hope to make Xolair available to as many people as possible living with food allergies in the U.S.”
The interim analysis, conducted on children and adolescents aged 1 to 17 years, revealed positive results. Compared to the placebo, Xolair significantly increased the threshold for allergic reactions to peanuts, milk, eggs, and cashews. Safety findings were consistent with Xolair’s known benefit-risk profile.
Furthermore, Genentech and Novartis Pharmaceuticals Corporation support the National Institute of Allergy and Infectious Diseases (NIAID)-sponsored Phase III OUtMATCH study, part of the NIH. If approved, Xolair could address the rising prevalence of food allergies, providing relief for millions of affected individuals.
