Genentech, a member of the Roche Group, has announced the FDA approval of Xolair® (omalizumab) for reducing allergic reactions, including anaphylaxis, linked to accidental exposure to one or more foods in adults and pediatric patients one year of age and older with IgE-mediated food allergy. To avoid the risk of severe reactions, patients on Xolair for food allergies should continue to avoid known food allergens, and Xolair is not intended for emergency treatment of allergic reactions or anaphylaxis.
This FDA approval extends Xolair’s availability for patients with IgE-mediated food allergies, making it the first medicine of its kind to receive such approval. The drug aims to address the growing prevalence of food allergies and the demand for treatments to prevent potentially life-threatening allergic responses.
Dr. Levi Garraway, Genentech’s CMO and Head of Global Product Development, underscored the need for this treatment, mentioning its established efficacy and safety profile built over two decades since Xolair’s initial approval for allergic asthma.
The Phase III OUtMATCH NIH-sponsored study provided the positive data for approval, showing a significant proportion of patients (ranging from 1 to 55 years old) could tolerate small amounts of common food allergens. The study was conducted at various clinical sites across the U.S., including the Johns Hopkins Children’s Center and Stanford School of Medicine.
Results from OUtMATCH will be presented at a late-breaking symposium at the 2024 AAAAI Annual Meeting. Sung Poblete, CEO of Food Allergy Research and Education (FARE), emphasized the importance of new preventative approaches to safeguard against severe reactions due to food allergies, acknowledging the challenges faced by the affected community.
This approval positions Xolair as an important option for managing food allergies and reflects Genentech’s commitment to addressing unmet needs in the area of allergic diseases.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
