Roche’s Xolair Shows Effectiveness In Oral Immunotherapy For Food Allergy Treatments

Roche has announced new positive findings from Stages 2 and 3 of the NIH-sponsored Phase III OUtMATCH study. The results further support the effectiveness of Xolair® (omalizumab) in treating individuals with one or more food allergies.

“Food allergies are becoming more common, leaving millions of families to grapple with constant vigilance, strict dietary restrictions and disruptions to everyday activities. These findings equip healthcare providers with valuable data on omalizumab and oral immunotherapy, enabling them to continue to address the diverse needs and treatment goals of their food allergy patients,” said R. Sharon Chinthrajah, M.D., OUtMATCH co-lead study investigator and associate professor of medicine, Stanford School of Medicine, Sean N. Parker Center for Allergy and Asthma Research.

Stage 2 of the study demonstrated that Xolair outperformed multi-allergen oral immunotherapy (OIT) in terms of efficacy and safety. This was the first head-to-head comparison between the two approaches. OIT involves gradually increasing exposure to food allergens, but the study found that high rates of adverse events led to many patients discontinuing treatment in the OIT group.

Levi Garraway, M.D., Ph.D., Roche's Chief Medical Officer and Head of Global Product Development, stated, “These latest data provide additional evidence demonstrating the importance of Xolair as a treatment option for the food allergy community. We are deeply grateful to the leading research institutions who partnered with us on this groundbreaking study and the inspiring dedication of the study’s participants and their families.”

Additionally, preliminary data from Stage 3 of the OUtMATCH study provided early insights into introducing allergenic foods into a patient’s diet after discontinuing Xolair. These findings were presented as new symposiums at the 2025 American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting.