FDA OKs Xolair as First Drug for Multiple Food Allergies

The FDA has greenlit Xolair, a medication developed by Novartis Pharmaceuticals and Genentech, as the first drug for reducing allergic reactions to one or more foods. Xolair is intended for patients aged one year and older with immunoglobulin E (IgE)-mediated food allergies who accidentally ingest triggering foods.

The injectable drug allows patients to tolerate higher amounts of allergens without severe reactions when inadvertently exposed, offering a significant breakthrough in managing food allergies. However, it is crucial to note that Xolair is not a cure and patients must continue avoiding foods they are allergic to.

The FDA emphasized that Xolair is not for immediate emergency treatment of allergic reactions, including anaphylaxis. Patients can take the drug every two to four weeks, depending on various factors, to mitigate the severity of allergic reactions.

The approval is a result of the Phase 3 OUtMATCH study, which assessed Xolair’s safety and efficacy in 168 patients aged 1 to 55 with allergies to peanuts and at least two other foods, such as milk, wheat, or cashews. The most common side effects of Xolair are fever and injection site reactions.

Reshema Kemps-Polanco, an executive at Novartis, described the approval as a “paradigm shift” in managing food allergies. Xolair was initially approved by the FDA in 2003 to treat moderate to severe persistent allergic asthma in patients aged 12 and older. Over the years, it has also been used to treat chronic spontaneous urticaria (chronic hives) and chronic rhinosinusitis with nasal polyps.

Since its approval, Xolair has been used by more than 700,000 patients in the U.S. The FDA granted priority review to Xolair in December, highlighting its importance in addressing allergic reactions to multiple foods.