The Food and Drug Administration this month approved a drug that reduces the risk of severe reactions in children and adults exposed to traces of peanuts, tree nuts, milk, dairy products and other food allergens — a move that could dramatically improve the quality of people’s lives. cope with these risks. The results of the clinical trial supporting the decision were released on Sunday.
Although the drug Xolair offers a new level of protection to people who may have life-threatening reactions to common foods, and especially to those who are allergic to several foods, its use comes with important warnings.
Does Xolair cure food allergies?
No. Xolair is not a cure for food allergies, nor can it be used to treat acute reactions. People taking Xolair should continue to avoid foods to which they are allergic.
But Xolair can significantly reduce the chances that people with severe food allergies will develop acute reactions if they ingest small amounts of allergens, such as peanuts or eggs in prepared foods, or are exposed to trace amounts in some other way.
People must take the drug continuously to benefit from its protection. Even in this case the drug does not completely eliminate the risk.
How does it work?
Xolair is a synthetic antibody that works by binding to immunoglobulin E, a component of the immune system, preventing it from arming key immune cells responsible for triggering allergic reactions.
Who benefits most from taking Xolair?
Xolair helps protect against more severe allergic reactions, particularly those driven by immunoglobulin E. The drug may be especially helpful for people who have allergies to multiple foods and must constantly avoid them all, which can be difficult, and for those who eat a lot of food prepared by others (such as college students on meal plans).
It is approved for adults and children 1 year and older. (Infants younger than 1 year were not included in the clinical study.)
How well does it work?
Xolair reduces, but does not eliminate, the risk of having a serious reaction to a particular food. People with these allergies should continue to exercise caution and avoid foods to which they are allergic; they should read food labels and inform others of their allergies. They or their caregivers should continue to carry epinephrine, a drug that can reverse the symptoms of anaphylaxis, at all times.
How is Xolair administered?
One disadvantage of the drug is that it must be given by injection, usually into the arm. The injections are administered every two to four weeks, with dosing intervals tailored to the patient.
Clinical trial participants were found to benefit after 16-20 weeks of treatment. But protection against severe reactions appears to last only as long as patients continue treatment.
Does Xolair have any side effects? Is it safe for long-term use?
Although the drug has only recently been shown to reduce the risks of food allergies, it has been on the market for 20 years for other uses, including asthma caused by allergies and chronic hives. So its safety profile is quite well known.
The most common side effects experienced by participants in the recent study were injection site reactions and fever. In rare cases, the drug itself can cause life-threatening anaphylaxis: It has been shown to occur after the first dose of Xolair, according to the FDA, as well as a year or more after starting treatment.
For this reason, Xolair must be administered in a healthcare setting equipped to treat anaphylaxis. The label also warns of rare side effects such as joint pain, skin rashes and parasitic infections.
How much does Xolair cost? Is it covered by insurance?
Although Xolair has been used for other conditions since 2003 and the National Institutes of Health helped fund the new study, Xolair has a high list price: about $2,900 a month for children with food allergies and about $5,000 for adults, according to Genentech. , the producer.
But now that it has been approved for severe food allergies, insurance plans are expected to cover it at least partially. Patient assistance programs are available through Genentech Access Solutions.
For eligible patients who have commercial health insurance, Genentech also offers the Xolair Co-Pay program, which can help cover the cost of treatment.