The Federal Food and Drug Administration (FDA) recently approved Xolair to build resistance to food allergy reactions during accidental exposures.
Dr. Sandra Hong, medical director of the Food Allergy Center of Excellence at Cleveland Clinic, said the injectable can also bring peace of mind to people who suffer from food allergies by reducing reaction severity.
Xolair, or omalizumab, has previously been used to treat asthma, chronic hives and nasal polyps. The FDA has approved the use of Xolair in people ages 1 and older.
It won't eliminate or cure food allergies, but it can help people build a higher tolerance when exposed, Dr. Hong said. The drug binds to immunoglobulin E (IgE), the antibody that triggers allergic reactions, and blocks IgE from binding to its receptors, according to the FDA.
"This medication is only for patients with IgE-mediated food allergies," she explained. IgE-mediated food allergies are characterized by the rapid onset of symptoms following exposure, such as milk, egg, soy, wheat, peanut, and shellfish allergies.
It is only intended for people with physician-tested IgE food allergies that can lead to reactions such as hives, gastrointestinal issues, respiratory problems or decreased blood pressure.
It's not meant for people with food sensitivities or intolerances like celiac disease or Food Protein Induced Enterocolitis Syndrome (FPIES), Dr. Hong said.
It also means people with food allergies should still keep their EpiPens.
"It won't change our recommendations. We are going to ask that families and patients continue to do complete avoidance techniques. It is most likely protective for accidental exposures," Hong said.
Patients will also have to consider costs and insurance coverage. A spokesperson for Genentech, the maker of Xolair, said the estimated monthly list price for the drug is around $2,900 for children and $5,000 for adults.
The clinical trials for using Xolair for food allergies tested 168 children and adults with a peanut allergy and at least two other food allergies. Of those who received Xolair, 68% were able to eat a single dose of peanut protein without experiencing moderate to severe allergic symptoms, compared to 6% who received placebo. However, 17% of those who received Xolair had no significant change in the amount of peanut protein they could tolerate, meaning they could not tolerate 100 milligrams or more, which is why users still need to avoid foods they're allergic to and keep their auto injectors, like EpiPens, in case of emergency.
"In this study, there were a lot of patients that were able to tolerate up to four peanuts. However, there were some that couldn't even tolerate a quarter of the peanut, so you don't know if you're in which group, like you could be a responder and do great, or you could be one of these non-responders and not have that significant improvement," Hong said.
While patients will still need to avoid exposures, Hong said use of omalizumab can help put parents and children at ease when they can't always control their environment. For example, kids in school cafeterias or students who are heading to college for the first time.
"They may be allergic to milk and the concern is that they'll have a roommate that has their friends over and they're sitting on their roommate's, that has the milk allergies, bedspread, eating cheese pizza and getting milk on there," Hong explained.
Doctors are now trying to identify the patients best suited for omalizumab, she said.
It's taken as an injectable every two or four weeks, depending on dosage and patient body weight. Hong noted that clinical patients began seeing results after 16 to 20 weeks of receiving injections.
There are also risks to be considered in taking Xolair, Hong cautioned. The drug contains a "boxed warning," which the FDA adds to drug labels on products that can cause serious adverse reactions, particularly those that may lead to death or serious injury.
Hong said people can suffer anaphylaxis to Xolair, meaning prescribing doctors will need to monitor patients early on. Anaphylaxis has occurred after the first dose of Xolair, but also has occurred beyond one year after beginning treatment, according to the FDA.
"We typically will monitor them in the office after these injections, watch them for two hours afterward, because that's when patients are at their highest risk," Hong said.
