Novartis and Roche’s Xolair (omalizumab) has secured approval from the US Food and Drug Administration (FDA) to treat multiple food allergy reactions, just two months after the FDA granted the drug a priority review. 

Xolair is a monoclonal antibody that inhibits immunoglobulin E (IgE), first gaining approval in 2003 for allergic asthma, and has remained a market leader in that indication ever since. With the latest approval, the therapy can now be used to treat people with immunoglobulin E (IgE)-mediated food allergies, a classification that includes foods such as peanuts, milk, eggs, wheat, cashew nuts, hazelnut, or walnut.  

The FDA’s decision is based on results from the Phase III OUtMATCH study (NCT03881696), investigating the safety and efficacy of Xolair in patients ages one to 55. The trial, sponsored by the National Institutes of Health, met its primary endpoint – significantly increasing the amount of peanut it took to cause an allergic reaction compared to placebo. The secondary endpoint of increasing the amount of milk, egg, and cashew it took to cause an allergic reaction compared to placebo was also reached. 

In the study, 68% of patients who received Xolair for 16 to 20 weeks were able to tolerate at least 600 mg of peanut protein – equivalent to roughly two peanuts – without experiencing moderate to severe allergic symptoms, compared to 5% of those treated with placebo. Detailed results from the study will be presented in a few days at the American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting on 25 February 2024. 

However, despite this expanded use, a direct significant rise in revenues may not be on the horizon. While Roche reported $2.47bn in revenues for Xolair in 2023, according to GlobalData’s Pharma Intelligence Center, sales of Xolair are forecast to drop to $1.6bn in 2029. This is due to an expected influx of biosimilars following the patent expiry in March 2024 in Europe and November 2025 in the US.  

One of those biosimilar competitors is Alvotech, which signed an exclusive licensing agreement with Kashiv Biosciences to develop a biosimilar to Xolair, AVT23, in October 2023. The drug is currently in Phase III (NCT05774639) clinical development, set to conclude at the end of this year. 

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As a treatment for asthma, Xolair is administered subcutaneously once every two or four weeks, depending on body weight and total serum IgE level. The therapy is not indicated for emergency use of allergic reactions, such as anaphylaxis.  

In the announcement accompanying the approval, chief medical officer at Roche Levi Garraway said: “Today’s approval builds on 20 years of patient experience and an established efficacy and safety profile since Xolair was first approved in allergic asthma. We look forward to bringing this treatment to the food allergy community who have long awaited an advancement.”