Xolair Receives FDA Approval for Food Allergy Treatment
The U.S. Food and Drug Administration made a groundbreaking announcement on Friday, revealing that Xolair, a medication traditionally used in asthma treatment, has now been approved to assist individuals with food allergies in avoiding severe reactions.
Life-Changing Protection for Allergy Sufferers
Xolair, also known as omalizumab, is the first drug sanctioned by the FDA to diminish allergic reactions triggered by accidental exposure to food allergens. This approval extends to patients as young as one year old, allowing them to receive the medication through regular injections every two to four weeks, tailored to their weight and allergenic response.
Seventeen million Americans are estimated to have food allergies capable of inducing rapid, severe symptoms, including potentially fatal whole-body reactions. While individuals using Xolair must still avoid allergen-containing foods like peanuts, cashews, and milk, the medication enables them to tolerate higher quantities of these items without experiencing severe repercussions.
Scientific Validation and Potential Impact
The FDA’s decision is grounded in a study spearheaded by Dr. Robert Wood from Johns Hopkins Children’s Center and funded by the National Institutes of Health. This research demonstrated that Xolair enabled approximately 68% of participants with peanut allergies to tolerate up to 600 milligrams of peanut protein, significantly surpassing the 6% tolerance rate observed in the control group. Similar results were observed for other allergens such as tree nuts, milk, egg, and wheat.
Dr. Wood anticipates that between 25% to 50% of food allergy sufferers, especially children and young adults, may opt for Xolair treatment. Previously utilized “off-label” for food allergies, this full approval marks a significant advancement in allergy management.
Cost, Side Effects, and Warnings
Xolair, a monoclonal antibody medication, comes with a list price ranging from $2,900 to $5,000 per month, with most insured patients likely to pay reduced out-of-pocket expenses. Common side effects include injection site reactions and fever, while more severe issues like joint pain and malignancies have also been reported. Notably, Xolair carries a risk of anaphylaxis and should be administered in a healthcare setting equipped to address such reactions.