The FDA approval is based on data from the Phase 3 OUtMATCH study, which showed a high proportion of food allergy patients treated with Xolair could tolerate small amounts of peanut, milk, egg and cashew without an allergic reaction, compared to placebo
Roche’s subsidiary Genentech and Novartis are developing Xolair in the US. (Credit: F. Hoffmann-La Roche Ltd)
Roche has received the US Food and Drug Administration (FDA) approval for Xolair (omalizumab) to reduce food allergies in adults and children as young as one year.
Xolair is an antibody designed to target and block immunoglobulin E (IgE) to minimise the release of mediators throughout the allergic inflammatory cascade.
Genentech, a company of the Roche Group, and Novartis Pharmaceuticals are working together to develop and co-promote Xolair in the US.
The drug is indicated to reduce allergic reactions, including anaphylaxis, due to accidental exposure to one or more foods in adults and children with IgE-mediated food allergy.
It is the fourth FDA-approved indication for Xolair after persistent allergic asthma, chronic spontaneous urticaria (CSU) and chronic rhinosinusitis with nasal polyps (CRSwNP).
According to Roche, IgE-mediated food allergies are the most common and are typically characterised by the quick onset of symptoms after exposure to food allergens.
Xolair is the first and only FDA-approved treatment to reduce allergic reactions in people with one or more food allergies, said Roche.
People taking Xolair for food allergies should continue to avoid all foods they are allergic to (food allergen avoidance), and Xolair should not be used for emergency treatment.
Roche’s global product development head and chief medical officer Levi Garraway said: “Xolair offers patients and families an important new treatment option that can help redefine the way food allergies are managed and reduce the often-serious allergic reactions that can result from exposure to food allergens.
“Today’s approval builds on 20 years of patient experience and an established efficacy and safety profile since Xolair was first approved for allergic asthma. We look forward to bringing this treatment to the food allergy community who have long awaited an advancement.”
The FDA approval is supported by positive data from the Phase 3 OUtMATCH study of Xolair in paediatric and adult patients, aged between one and 55 years, allergic to peanuts and at least two other food allergens, including milk, egg, wheat, cashew, hazelnut, and walnut.
In the study, 68% of patients treated with Xolair tolerated at least 600mg of peanut protein without moderate to severe allergic symptoms, compared to 5% of those treated with placebo.
Also, a higher proportion of patients treated with Xolair compared to placebo tolerated at least 1,000mg of protein from milk, egg or cashew without moderate to severe allergic symptoms.
The drug showed a safety profile that was consistent with the known safety profile of Xolair across its additional indications and in previous clinical trials.
The most common adverse events in the study include injection site reaction and fever.
The OUtMATCH study is sponsored and funded by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH).
It was conducted by the Consortium for Food Allergy Research (CoFAR) at ten clinical sites across the US, led by Johns Hopkins Children’s Centre and Stanford School of Medicine.