The U.S. FDA has approved Roche and Novartis' injectable asthma drug, Xolair, as the first and only medicine for the reduction of allergic reactions, including anaphylaxis, that may occur with accidental exposure to foods.
The IgE-blocker, given as an injection under the skin every 2 or 4 weeks, is approved for adults and children aged 1 year and older with immunoglobulin E (IgE)-mediated food allergies — the most common type of food allergy, typically characterized by the rapid onset of symptoms following exposure to certain foods.
The approval is based on data from the NIH-sponsored phase 3 OUtMATCH study, which showed a significantly higher proportion of food allergy patients as young as 1 year treated with Xolair could tolerate small amounts of peanut, milk, egg and cashew without an allergic reaction, compared to placebo.
“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, associate director of the Division of Pulmonology, Allergy, and Critical Care at CDER.
Xolair was first approved in 2003, to treat moderate to severe asthma in certain patients. It won subsequent approvals in chronic idiopathic urticaria (hives) and nasal polyps. In 2021, the drug was approved for use via a prefilled syringe for self-injection.
