A drug designed to reduce allergic reactions to more than one type of food has been approved by the US Food and Drug Administration (FDA) for the first time, the organization announced on February 16.
Plenty of
Xolair, or omalizumab, is an injectable monoclonal
However, Xolair – approved for use in certain adults and children 1 year or older – is not intended for the immediate, emergency treatment of allergic reactions. Instead, it is recommended for repeat use to reduce the likelihood of severe reactions occurring and minimize the risks if they do.
Injections every
Xolair was initially approved for the treatment of allergic asthma in 2003, and is also approved for use in people with chronic spontaneous urticaria and chronic rhinosinusitis with nasal polyps.
“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,” Dr Kelly Stone, associate director of the Division of Pulmonology, Allergy, and Critical Care in the FDA’s Center for Drug Evaluation and Research, said in a
“While it will not eliminate food
The approval comes off the back of a successful
However, 17 percent of people had no significant change in their peanut protein tolerance. “As a result, continuation of strict allergen avoidance is still necessary, despite treatment with Xolair,” the FDA added.
Side effects included injection site reactions and fever, and the drug’s label cautions against anaphylaxis, malignancy, fever, joint pain, rash, and parasitic (worm) infection.
As a result, the FDA states Xolair should only be started in a healthcare setting and only for those without a history of known severe hypersensitivity to Xolair or any of its components.
Still, for those with food allergies – around 6 percent of people in the US, according to the