This Drug By Roche And Novartis Reduces Allergic Reactions Across Multiple Foods For People With Food Allergies

Monday, Roche Holdings AG RHHBY announced data from Stage 1 of the National Institutes of Health (NIH)-sponsored pivotal Phase 3 OUtMATCH study of Xolair (omalizumab) in patients allergic to peanuts and at least two other common foods were published in the New England Journal of Medicine.

The data was featured in a late-breaking symposium at the 2024 American Academy of Allergy, Asthma & Immunology Annual Meeting. 

Roche and Novartis AG NVS are co-developing and co-promoting Xolair.

The study showed that treatment with Xolair increased the amount of peanuts, milk, egg, wheat, and tree nuts (cashew, hazelnut, and walnut) that it took to cause moderate to severe allergic reactions in multi-food allergic people as young as one year. 

Safety findings were consistent with the known safety profile of Xolair across its approved indications and in previous clinical trials.

The FDA recently approved the expanded use of Xolair in children and adults with IgE-mediated food allergies based on the OUtMATCH data.

One hundred eighty patients ages 1 to 55 years old entered Stage 1 of the OUtMATCH study unable to tolerate up to 100 mg of peanut protein (equivalent to about one-third of a peanut) and up to 300 mg of at least two other food proteins among milk, egg, cashew, walnut, hazelnut, and wheat. 

Results showed that, compared to placebo, a statistically significant higher proportion of patients receiving Xolair could consume at least 600 mg of peanut protein and at least 1,000 mg of milk, egg, and cashew protein without experiencing moderate to severe allergic reactions. 

Additionally, compared to placebo, more patients receiving Xolair could consume at least 1,000 mg of walnut, hazelnut, and wheat protein without experiencing moderate to severe allergic reactions. 

It is estimated that food-related anaphylaxis results in 30,000 medical events treated in emergency rooms in the U.S. each year.

Roche said that while efficacy cannot be established from uncontrolled, open-label studies, for 38 children who continued Xolair for 24-28 weeks in an open-label extension, the percentage of patients who were able to consume 600 mg or more of peanut protein and 1,000 mg or more of egg, milk and/or cashew protein without moderate to severe dose-limiting symptoms was maintained.

Price Action: NVS shares are down 0.03% at $103.87 on the last check Monday.

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