Xolair becomes first medicine approved in US for food allergy

16 Feb 2024
firstwordpharma.com
Phase 3Drug Approval
Roche and Novartis' Xolair (omalizumab) has become the first medicine cleared in the US for reducing allergic reactions in adults and children as young as 1 year old with at least one food While the monoclonal antibody has been used off-label to treat food allergies, the new approval may help "redefine the way food allergies are managed and reduce the often-serious allergic reactions that can result from exposure to food allergens," said Levi Garraway, chief medical officer of Roche's Genentech unit.
Roche estimates there are about 3.4 million children and 13.6 million adults in the US who have been diagnosed with IgE-mediated food allergies, which are triggered by some 160 different foods, and the prevalence has been on the rise for the past two decades.
The list price for Xolair ranges from about $2900 a month for children to $5000 a month for adults, according to Genentech. The drug is also approved for severe persistent asthma, chronic rhinosinusitis with nasal polyps and chronic spontaneous urticaria.
The latest FDA nod is based on data from the NIH-sponsored Phase III OUtMATCH study. It included 471 patients who entered the trial unable to tolerate up to 100mg of peanut protein, and up to 300mg each of milk, egg and cashew protein.
Tops placebo across foods
After 16 to 20 weeks of treatment, each participant completed four food challenges to assess as the main endpoint their ability to eat a single dose of at least 600mg of peanut protein, the equivalent of about half a teaspoon of regular peanut butter. The primary endpoint was met by 68% patients in the Xolair group, compared to only 5% for placebo, a statistically significant difference.
Secondary goals included how they handled a single dose of at least 1000mg of milk, egg or cashew protein without experiencing moderate or severe allergic symptoms. Here, too, Xolair-treated patients were significantly more likely to tolerate these foods.
Specifically, 66% of Xolair subjects could tolerate two tablespoons of 1% milk, versus 11% for placebo; 67% tolerated one-quarter of an egg versus 0% with placebo; and 42% could consume 3.5 cashews without suffering moderate-to-severe reactions, compared to 3% for placebo. Roche cautioned that while patients in the OUtMATCH study managed these small amounts of food, Xolair should still be used with ongoing avoidance food allergens.
The most common adverse events in Xolair-treated patients were injection-site reactions and fever. More results from the study will be shared at the upcoming American Academy of Allergy, Asthma & Immunology (AAAAI) annual meeting later this month.
Novartis recently halted a Phase III trial of its experimental peanut allergy treatment ligelizumab (QGE031) due to ongoing optimisation of the drug's food allergy clinical programme. A company spokesperson said it is looking to test the optimised dosing in a new pivotal Phase III trial starting in the third quarter.
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