In a historic moment, the US Food and Drug Administration has greenlit the first medicine for severe allergy treatment. An injection, Xolair (omalizumab) was approved for use in adults and children one year and older to reduce the risk of severe allergic reactions. In a news release on Friday, the department said, “Xolair is intended for repeated use to reduce the risk of” and “not for the immediate emergency treatment of allergic reactions.”
Xolair receives greenlight from FDA for allergies
While Xolair was first recognised by the FDA in 2003, back then, it was only approved for “the treatment of moderate to severe persistent allergic asthma in certain patients,” the department says.
The news release also adds that the injectable drug is “also approved to treat chronic spontaneous urticaria and chronic rhinosinusitis with nasal polyps in certain patients.” The drug, which was developed by Genentech, aims to reduce severe allergic reactions brought on by accidental exposure to certain foods.
Some common side effects of Xolair include fever and a reaction to the injection site and may also trigger anaphylaxis, the FDA warns. Due to this, Genentech calls for the monitoring of patients who start to take the drug.
Xolair costs $2,900 a month for children and $5,000 a month for adults, per the Associated Press. The outlet adds that the price could go down in future.
{{/usCountry}}Xolair costs $2,900 a month for children and $5,000 a month for adults, per the Associated Press. The outlet adds that the price could go down in future.
{{/usCountry}}Dr. Kelly Stone says, “This newly approved use for Xolair will provide a treatment option to reduce the risk of harmful allergic reactions among certain patients with IgE-mediated food allergies,” per the FDA's statement.
The department also makes it clear the drug is by no means intended to be taken as treatment at the time of an allergic reaction. FDA further adds that patients taking the drug must continue to avoid consuming the 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,” Stone adds.