The U.S. Food and Drug Administration reports that a medicine used to treat asthma can now be used to help patients with food allergies prevent severe reactions.
Omalizumab, sold under the trade name Xolair, was the first treatment to be approved specifically to lessen allergic reactions brought on by unintentional contact to food allergens. Depending on their weight and body’s reaction to allergens, patients with allergies as early as one year old can have an injection of the medication every two to four weeks.
Food allergies of the kind that can result in immediate, severe symptoms, including possibly fatal whole-body reactions, are thought to affect 17 million people in the United States.
Xolair users need to keep avoiding foods like peanuts, cashews, hazelnuts, walnuts, milk products, and eggs that make them react. They can tolerate larger quantities of these items without experiencing severe side effects thanks to the medicine.
Many allergy sufferers, as well as their families, constantly worry about being exposed to allergens, which makes them avoid social settings like going out to eat.
“Having this protection is going to be life-changing,” stated Dr. Robert Wood, who oversees the Johns Hopkins Children’s Center’s pediatric allergy division.
The National Institutes of Health-funded study headed by Wood served as the foundation for the FDA’s ruling. It revealed that, in comparison to around 6% of individuals who received fake injections, roughly 68% of participants with peanut allergies were able to take roughly 600 milligrams, or roughly 1/2 teaspoon, of peanut protein while using Xolair.
According to a study abstract, the outcomes were comparable for other allergies such wheat, milk, eggs, and tree nuts. Later this month, the whole findings should be published in a peer-reviewed publication and presented at a meeting.
Wood projected that between 25% and 50% of individuals with food allergies—especially kids and young adults—would choose to take Xolair.
According to Dr. Ruchi Gupta, head of Northwestern University’s Center for Food Allergy & Asthma Research, the medication has been used “off-label” to treat food allergies. She applauded the product’s complete approval.
A monoclonal antibody, such as Xolair, is a type of medication that functions by preventing the body’s normal reaction to allergens. Since its initial approval in 2003, it has been used to treat persistent hives, nasal polyps, and asthma. Produced by pharmaceutical companies Novartis and Roche, it’s distributed by Genentech, a division of Roche.
Injection site reactions and fever are the most frequent adverse effects of Xolair; nevertheless, the FDA has also reported that the medication has been linked to joint discomfort, rash, parasite infections, cancer, and abnormal laboratory tests. The medication itself, Xolair, has a warning label that states it can cause anaphylaxis and should only be started in a medical facility that is prepared to handle the reaction.
The drug is not authorized for use in treating allergic responses in an emergency.
According to Genentech, the list price of Xolair varies from approximately $2,900 per month for children to $5,000 per month for adults. According to the business, the majority of insured patients usually pay less out of pocket.