FDA Approves Xolair to Treat Allergic Reactions in People with Multiple Food Allergies
The US Food and Drug Administration (FDA) has granted approval for Xolair, a medication developed by Genentech and Novartis, to reduce the severity of accidental allergic reactions in individuals allergic to multiple foods.
Initially approved in 2003 for moderate to severe allergic asthma, Xolair is administered through injections, ranging from 75mg to 600mg, once every two or four weeks. The FDA emphasises that Xolair is not intended for immediate emergency treatment but can help lower the risk of allergic reactions in certain adults and children over the age of one after accidental exposure to foods like peanuts, milk, egg, and wheat.
Xolair does not eliminate food allergies but, when used repeatedly, helps mitigate health impacts in case of accidental exposure. The estimated monthly cost ranges from $2,900 for children to $5,000 for adults, with actual costs varying based on insurance coverage. Despite the benefits, the FDA stresses that patients receiving Xolair injections must continue to avoid the foods they are allergic to.
The approval is based on a phase 3 study involving 168 participants aged 1 to 55 with multiple food allergies. Xolair showed efficacy, with 68% of patients able to tolerate a significant amount of peanut protein without severe allergic symptoms, compared to 6% in the placebo group. However, 17% of those who received the medication experienced no significant improvement. Xolair does come with potential side effects, including reactions at the injection site, joint pain, rashes and fever.
Living with food allergies affects an estimated 6% of the US population, according to the CDC, and can lead to potentially life-threatening reactions. Kenneth Mendez, CEO of the Asthma and Allergy Foundation of America, acknowledges the stress of navigating daily life with food allergies and sees the FDA approval of Xolair as offering hope to those seeking new ways to manage their conditions.
