FDA Approves Xolair: A Groundbreaking Medication for Food Allergies
Living with food allergies can be a constant source of anxiety for millions of people in the United States. The fear of accidental exposure to allergens often leads individuals and their families to avoid dining out and social situations altogether. However, there is now a glimmer of hope for those suffering from severe food allergies. The U.S. Food and Drug Administration (FDA) has recently approved Xolair, a medication primarily used to treat asthma, as the first-ever drug to reduce allergic reactions caused by multiple food triggers.
Xolair, also known as omalizumab, offers a breakthrough in the management of food allergies. Patients as young as one year old can receive the drug through injection every two to four weeks, depending on their weight and individual response to allergens. This approval marks a significant milestone in the medical field, as an estimated 17 million Americans suffer from food allergies that can lead to life-threatening reactions.
It is important to note that Xolair does not eliminate the need for individuals to avoid the foods that trigger their allergies. Instead, it allows them to tolerate higher amounts of these foods without experiencing severe reactions. Common allergens such as peanuts, cashews, hazelnuts, walnuts, milk products, and eggs still need to be avoided.
Dr. Robert Wood, director of the pediatric allergy division at Johns Hopkins Children’s Center, expressed his excitement about the FDA’s decision. He believes that this approval will be life-changing for many individuals and their families. The FDA’s decision was based on a study led by Dr. Wood and funded by the National Institutes of Health. The study demonstrated that Xolair enabled approximately 68% of participants with peanut allergies to tolerate around 600 milligrams of peanut protein, compared to only 6% of those who received placebo injections. Similar results were observed for other allergens such as tree nuts, milk, egg, and wheat.
Dr. Wood estimates that between 25% and 50% of people with food allergies, particularly children and young adults, will choose to use Xolair. Although the drug has been used “off-label” to treat food allergies in the past, this full approval by the FDA is a significant step forward. Dr. Ruchi Gupta, director of the Center for Food Allergy & Asthma Research at Northwestern University, welcomed the approval and emphasized the importance of having a dedicated medication for food allergies.
Xolair is classified as a monoclonal antibody, a type of treatment that works by blocking the body’s natural response to allergens. It was initially approved in 2003 and has been successfully used to treat asthma, nasal polyps, and chronic hives. Manufactured by Novartis and Roche, Xolair is distributed by Roche subsidiary Genentech.
While Xolair offers promising benefits, it is essential to be aware of potential side effects. The most common side effects include injection site reactions and fever. However, the FDA has also noted that the drug has been associated with joint pain, rash, parasitic infections, malignancies, and abnormal laboratory test results. It is crucial to start Xolair treatment in a healthcare setting equipped to manage potential anaphylactic reactions. Furthermore, Xolair is not approved for emergency treatment of allergic reactions.
The cost of Xolair varies depending on the age of the patient. For children, the list price is approximately $2,900 per month, while adults can expect to pay around $5,000 per month. However, most insured patients typically pay less out of pocket.
The approval of Xolair by the FDA brings hope to millions of individuals living with severe food allergies. It offers them an opportunity to lead more normal lives by reducing the risk of severe reactions caused by accidental exposure to allergens. While Xolair is not a cure for food allergies, it represents a significant step forward in managing this potentially life-threatening condition. With ongoing research and advancements in medical science, the future holds even more promise for individuals affected by food allergies.