Emerging asthma option: how Novartis’ Xolair is expanding into food allergy care

Novartis’ antibody Xolair, long established for asthma and chronic hives, is now FDA-approved to help reduce reactions to accidental food allergen exposure in certain patients. The move broadens the drug’s use beyond respiratory disease into a high-need allergy segment.

Edited by ad hoc news Flagship & Bestseller Desk. Reviewed before publication on 06/15/2026 at 4:58 PM ET. Details in the imprint.

For more than two decades, Xolair (omalizumab) from Novartis and partner Roche has been a mainstay biologic for patients with moderate to severe allergic asthma and chronic spontaneous urticaria who do not get adequate control from standard therapies. In early 2024, the monoclonal antibody added a new US Food and Drug Administration indication as the first medicine approved to help reduce allergic reactions, including anaphylaxis, that may occur with accidental exposure to one or more foods in certain adults and children with IgE-mediated food allergy. This expansion turns Xolair into one of the most versatile biologics in allergy and immunology and positions it as a flagship product in Novartis’ broader immunology portfolio. An FDA approval announcement from Roche outlines the food allergy label and supporting data.

What Xolair does and how the new food allergy label changes the picture

Xolair is a humanized monoclonal antibody that targets immunoglobulin E (IgE), a key antibody involved in allergic responses, thereby reducing the ability of allergens to trigger the cascade that leads to symptoms like wheeze, hives or potentially life-threatening anaphylaxis. The drug is administered by subcutaneous injection, with dosing based on a patient’s baseline IgE level and body weight, and can be given every two or four weeks in a clinic or, for some indications and patients, at home after appropriate training. In asthma, it is typically prescribed as an add-on maintenance therapy in patients whose disease remains uncontrolled despite inhaled corticosteroids and long-acting beta agonists, with clinical trials demonstrating reductions in exacerbations, unscheduled healthcare visits and corticosteroid use for many responders over time.

With the 2024 US approval for IgE-mediated food allergy, Xolair is now indicated to reduce allergic reactions, including anaphylaxis, that may occur with accidental exposure to one or more foods, when used alongside ongoing allergen avoidance and epinephrine emergency preparedness. The label applies to adults and children aged 1 year and older with documented IgE-mediated allergy to common foods such as peanut, milk, egg or tree nuts, based on positive skin or blood testing and a history of clinical reactions. In the pivotal phase 3 OUtMATCH trial, patients receiving Xolair could tolerate substantially higher doses of peanut protein without dose-limiting allergic symptoms compared with placebo, and similar protective effects were seen across multiple other food allergens, suggesting a broad desensitizing impact across the food allergy spectrum. A New England Journal of Medicine publication describes the OUtMATCH results and their clinical implications.

The expansion into food allergy does not change the longstanding role of Xolair in asthma and chronic spontaneous urticaria, where it remains approved as an add-on therapy in patients 6 years and older with moderate to severe persistent allergic asthma and in those 12 years and older with CSU who remain symptomatic despite H1 antihistamines. For CSU, Xolair is typically used after high-dose second-generation antihistamines fail to control wheals and pruritus, with many patients achieving marked reductions in hive severity and itch intensity over several months of treatment. Across its indications, safety data accumulated from extensive post-marketing experience show that common adverse events include injection-site reactions, transient headaches and infections of the upper respiratory tract, while rare but serious risks such as anaphylaxis require patients to be monitored after injection and educated about emergency management.

From a practical standpoint, Xolair is supplied as prefilled syringes or vials at various strengths, and in the United States it is generally administered in specialty clinics, hospital outpatient settings or allergy practices that can manage potential hypersensitivity reactions. The list price for Xolair in the US varies with dose and frequency but often falls into the several-thousand-dollar range per month for high-dose regimens, with actual patient out-of-pocket costs determined by insurance coverage, co-pay assistance programs and institutional contracts. While pricing details differ by indication and payer, the new food allergy label is expected to drive increased demand among pediatric and young adult patients whose families are seeking an additional layer of protection beyond meticulous allergen avoidance in daily life.

For Novartis, which co-commercializes Xolair in the United States and several other markets, the drug has long been an important contributor within its Innovative Medicines segment, though detailed, product-level revenue disclosures are limited because of the collaboration structure with Roche and regional co-marketing arrangements. Market analysts nevertheless continue to view Xolair as a foundational asset in the company’s respiratory and immunology franchise and see the food allergy indication as a way to extend the lifecycle of the molecule against the backdrop of biosimilar pressure in some regions and the emergence of newer biologics targeting pathways such as IL-5, IL-4/IL-13 and TSLP. Novartis’ quarterly results presentations categorize Xolair among key immunology and respiratory products. Shares of Novartis (CH0012005267) trade on the SIX Swiss Exchange in Zurich and as an American Depositary Receipt on the New York Stock Exchange, where the ADR last changed hands in recent sessions in the low-$100 range.

Xolair key facts at a glance

• Product: Xolair (omalizumab)
• Manufacturer: Novartis AG (co-marketed with Roche Holding AG)
• Category: Flagship/Bestseller biologic for allergy, asthma and chronic hives
• Launch date: Initial FDA approval for allergic asthma in 2003; additional indications including chronic spontaneous urticaria and IgE-mediated food allergy followed in later years
• MSRP / Price: US list price typically in the thousands of dollars per month for high-dose regimens, varying by weight, IgE level and dosing frequency
• Availability: Prescription biologic available in the US and many international markets through hospitals, specialty pharmacies and allergy/immunology clinics
• Target audience: Patients with moderate to severe allergic asthma, chronic spontaneous urticaria or IgE-mediated food allergy who remain inadequately controlled on standard therapies
• Key differentiator / USP: First-in-class anti-IgE antibody with a newly approved food allergy indication, offering broad protection across multiple allergens when used with avoidance measures

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