FDA approves first medication to reduce allergic reactions

Peanut butter

The US Food and Drug Administration (FDA) has approved monoclonal antibody Xolair (omalizumab) for immunoglobulin E-mediated food allergy in some adults and children one year or older for the reduction of allergic reactions (Type I).

The FDA said that Xolair is intended for repeated use to reduce the risk of allergic reactions and is not approved for the immediate emergency treatment of allergic reactions, including anaphylaxis.

Xolair was originally approved in 2003 for the treatment of moderate to severe persistent allergic asthma. It is also approved to treat chronic spontaneous urticaria and chronic rhinosinusitis with nasal polyps.

“This newly approved use for Xolair will provide a treatment option to reduce the risk of harmful allergic reactions among certain patients with IgE-mediated food allergies,” said Kelly Stone, Associate Director of the Division of Pulmonology, Allergy, and Critical Care in the FDA’s Center for Drug Evaluation and Research. “While it will not eliminate food allergies or allow patients to consume food allergens freely, its repeated use will help reduce the health impact if accidental exposure occurs.”

Xolair binds to immunoglobulin E (IgE), the antibody type that triggers allergic reactions, and blocks IgE from binding to its receptors.

Omalizumab clinical trial

The FDA approval is based on data from a planned interim analysis of a Phase III clinical trial sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of NIH. NIAID funds the ongoing trial with additional support from and collaboration with Genentech, a member of the Roche Group, and Novartis Pharmaceuticals Corporation. The two companies collaborate to develop and promote omalizumab, and are supplying it for the trial. The National Center for Advancing Translational Sciences, also part of NIH, supports some of the staff, space and services used to conduct the trial.

The Omalizumab as Monotherapy and as Adjunct Therapy to Multi-Allergen OIT in Food Allergic Children and Adults (OUtMATCH) was conducted by investigators in the NIAID-funded Consortium for Food Allergy Research.

Of those who received Xolair, 68% (75 of 110 subjects) were able to eat the single dose of peanut protein without moderate to severe allergic symptoms (e.g., whole body hives, persistent coughing, vomiting), compared to 6% (three of 55 subjects) who received placebo.

Of note, however, 17% of subjects receiving Xolair had no significant change in the amount of peanut protein tolerated (could not tolerate 100mg or more of peanut protein). As a result, continuation of strict allergen avoidance is still necessary, despite treatment with Xolair.

Treatment significance

“People with food allergies and their caregivers need to maintain constant vigilance to avoid foods that could cause a potentially life-threatening allergic reaction. This is extremely stressful, especially for parents of young children,” said Jeanne Marrazzo, Director of NIAID. “Although food avoidance remains critical, the findings reported today show that a medicine can help reduce the risk of allergic reactions to common foods and may provide protection from accidental exposure emergencies.”

An estimated 7.6% of children in the United States – roughly 5.5 million kids – have food allergies. Previously, the only available treatment for food allergy was oral immunotherapy, or OIT, which involves daily ingestion of a specific food allergen in gradually increasing doses up to a maintenance amount.

Diana Spencer, Senior Digital Content Editor, DDW

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