The Food and Drug Administration (FDA) has approved a medication that can help reduce the reaction when children and adults with food allergies inadvertently come into contact with those foods.
Xolair (omalizumab) from Genentech can be used for certain people ages 1 year and older with food allergies, which affect nearly 6% of people and can cause life-threatening reactions.
“I think our patients for years have been looking for treatment options and I think this is exciting progress for them,” said Drew Bird, M.D., FAAP, chair of the AAP Section on Allergy and Immunology Executive Committee. “… Having a product that may provide protection against allergic reactions in allergic patients could significantly improve their quality of life.”
Xolair is a monoclonal antibody that binds to immunoglobulin E (IgE) and blocks it from binding to its receptors. It is given as repeated subcutaneous injections that can reduce allergic reactions when a patient is inadvertently exposed to a food allergen. However, officials caution patients still must avoid foods to which they are allergic, and the medication is not approved for emergency treatment of allergic reactions including anaphylaxis.
Dr. Bird, professor and interim chief in the Division of Allergy and Immunology at UT Southwestern Medical Center in Dallas, was involved in clinical trials for Xolair at Children’s Health, where he serves as director of the Food Allergy Center. Children’s Health was among several sites for the trials that were sponsored by the National Institutes of Health.
Results from a double-blind, placebo-controlled study of 168 children and adults with food allergies found that significantly more subjects undergoing the treatment could tolerate small amounts of peanut, milk, egg and cashew without moderate to severe allergic symptoms compared to those receiving a placebo, according to the FDA.
"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," Kelly Stone, M.D., Ph.D., associate director of the Division of Pulmonology, Allergy, and Critical Care in the FDA's Center for Drug Evaluation and Research, said in a press release. "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."
The most common side effects of Xolair include injection site reactions and fever. Xolair also comes with warnings and precautions regarding anaphylaxis, cancer, fever, joint pain, rash, parasitic (worm) infection and abnormal laboratory tests. It also has a boxed warning for anaphylaxis, which can be life-threatening.
However, Dr. Bird said the medication has years of safety data. It was approved in 2003 for treatment of moderate to severe persistent allergic asthma, according to the FDA. It also has been approved to treat chronic spontaneous urticaria and chronic rhinosinusitis with nasal polyps.
“We have years of experience using this medication, and it’s really proven effective and safe for most patients,” Dr. Bird said. “I think our patients will be reassured by the years of safety data that exist.”
Dr. Bird suggested pediatricians with a patient who may be eligible for Xolair reach out to an allergist as an accurate diagnosis is important to reduce unnecessary cost and risk.
Xolair treatments should be started in a health care setting equipped to manage anaphylaxis, according to the FDA. Selected patients may then be able to continue with treatment at home if they tolerate the treatment without anaphylaxis.
Resources
- Full prescribing information for Xolair
- FDA press release on its approval of Xolair including more detailed trial data
- AAP clinical report Guidance on Completing a Written Allergy and Anaphylaxis Emergency Plan
- AAP clinical report Epinephrine for First-aid management of Anaphylaxis
- Web-based learning tool, Managing Allergy & Anaphylaxis in the Pediatric Clinic and Beyond
- Information from the FDA on food allergies
- Information for parents from HealthyChildren.org on anaphylaxis, http://bit.ly/2blTWBT and how to use an epinephrine auto-injector, http://bit.ly/2wITftC.
