FDA approves a drug to treat severe food allergies, including milk, eggs and nuts
Milk, eggs, walnuts and peanuts — this is not a grocery list, but some of the food allergies that could be more easily tolerated with a newly approved drug.
Xolair, developed by Genentech, was greenlit by the Food and Drug Administration on Friday to help reduce severe allergic reactions brought on by accidental exposure to certain foods. It is considered the first medication approved by the FDA that can help protect people against multiple food allergies.
The medication is not intended for use during an allergic reaction. Instead, it is designed to be taken repeatedly every few weeks to help reduce the risk of reactions over time. The FDA said people taking the drug should continue to avoid foods they are allergic to.
"While it will not eliminate food allergies or allow patients to consume food allergens freely, its repeated use will help reduce the health impact if accidental exposure occurs," said Kelly Stone with the FDA's Center for Drug Evaluation and Research.
Some of the most common side effects include fever and a reaction to the injection site. The drug also warns that the medication itself can trigger anaphylaxis. Genentech advises that a heath care provider monitors a person who is starting to use Xolair.
The cost of the medication ranges from $2,900 a month for children and $5,000 a month for adults, though the cost could be brought down with insurance, according to the Associated Press.
As of 2021, about 1 in 16 adults in the U.S. have a food allergy and it impacts women and Black adults at higher rates, according to the Centers for Disease Control and Prevention. There is no current cure for food allergies.
Xolair has already been approved by the FDA to treat some cases of persistent asthma triggered by allergies, chronic hives and chronic inflammatory sinus disease with nasal polyps.
The drug is administered by injection every two or four weeks. Over time, Xolair has proven to help some people tolerate foods they are allergic to, according to a study sponsored by the National Institute of Allergy and Infectious Diseases.
In a trial with 168 patients who were allergic to peanuts and at least two other foods, 68% of people who took Xolair for 4 to 5 months were able to consume about 2.5 peanuts without symptoms like body hives, persistent coughing or vomiting, according to the FDA.
The study also found that Xolair was effective after 4 to 5 months in 67% of people allergic to eggs; 66% of people allergic to milk; and 42% of people allergic to cashews. These results were based on small amounts of each food — a quarter of an egg, two tablespoons of 1% milk and 3.5 cashews, according to Genentech.