U.S – The U.S. Food and Drug Administration (FDA) has granted approval for Xolair (omalizumab) injection as a treatment for immunoglobulin E (IgE)-mediated food allergies in specific adults and children aged one year and above.

This approval marks a significant advancement in the field of allergy management, offering hope to individuals grappling with severe allergic reactions to various foods.

Xolair’s approval is a pivotal development in addressing the pressing need for effective interventions against IgE-mediated food allergies, which can trigger life-threatening allergic reactions, including anaphylaxis, upon accidental exposure to specific food allergens.

In the US alone, 5.8 million children live with food hypersensitivity, according to FoodAllergy.org. However, Johns Hopkins Medicine notes that nearly five percent of children under the age of five live with food allergies.

Eggs, milk, peanuts, tree nuts, wheat, soy, fish, and shellfish are among the most common allergens, with potentially severe reactions posing a constant threat to affected individuals.

Xolair stems from a study, led by Dr. Robert Wood of Johns Hopkins University School of Medicine and Dr. Sharon Chinthrajah of Stanford University School of Medicine. It demonstrates the efficacy of a 16-week course of the monoclonal antibody omalizumab in protecting children living with multiple food allergies from severe allergic reactions due to accidental exposure.

While the treatment does not eliminate food allergies or permit unrestricted consumption of allergenic foods, it serves as a crucial tool in reducing the risk of severe allergic reactions in affected individuals.

Dr. Kelly Stone, Associate Director of the Division of Pulmonology, Allergy, and Critical Care at the FDA’s Center for Drug Evaluation and Research, commends the approval of Xolair as a milestone in allergy treatment.

The therapy’s demonstrated effectiveness in reducing allergic reactions underscores its potential to mitigate the health impacts associated with accidental food allergen exposure.

Xolair’s safety and efficacy in mitigating allergic reactions were established through rigorous clinical trials involving pediatric and adult subjects allergic to peanut and at least two other foods.

The trials demonstrated that Xolair considerably increased the percentage of subjects able to tolerate specific food allergens without experiencing moderate to severe allergic symptoms, such as skin, respiratory, or gastrointestinal reactions.

Participants who completed the antibody treatment showed a notable increase in tolerance to allergenic foods, including peanuts, tree nuts, egg, milk, wheat, cashew, walnut, and hazelnut. Notably, nearly 67 percent of participants who completed the treatment were able to consume a single dose of 600 milligrams or more of peanut protein without experiencing moderate or severe allergic reactions, compared to less than seven percent of those who received a placebo.

Boxed warning and precautions

While Xolair offers promising benefits in reducing allergic reactions, it is crucial for patients to continue strict avoidance of allergenic foods and be prepared for emergency management of allergic reactions, including anaphylaxis, with appropriate interventions such as epinephrine administration.

Xolair comes with essential warnings and precautions, including the risk of anaphylaxis, malignancy, fever, joint pain, rash, parasitic infections, and abnormal laboratory test results.

Markedly, Xolair carries a boxed warning for anaphylaxis, emphasizing the critical importance of administering the medication in healthcare settings equipped to manage severe allergic reactions.

The approval of Xolair reflects a collaborative effort between regulatory authorities, healthcare professionals, and pharmaceutical innovators. Genentech, the manufacturer of Xolair, has played a pivotal role in bringing this therapy to fruition.

Jeanne Marrazzo, Director of the National Institute of Allergy and Infectious Diseases (NIAID), emphasized the potential of omalizumab therapy to mitigate the risk of life-threatening allergic reactions and provide a sense of security for affected individuals and their families.

Sterling Crew, President of the Institute of Food Science, hailed the FDA’s approval as a remarkable milestone in allergy management, highlighting the importance of continued vigilance and allergen management practices in the food industry.

Despite the promising advancements in medical science, Crew emphasized the need for comprehensive allergen risk assessments and stringent safety measures to protect consumers with food hypersensitivity from potential allergen exposures.

Moving forward, ongoing research conducted by the NIAID-funded Consortium for Food Allergy Research (CoFAR) will further investigate the efficacy and safety of omalizumab therapy in a broader population of children, adolescents, and adults with food allergies.

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