FDA grants priority review to omalizumab for food allergies

The US Food and Drug Administration (FDA) has granted priority review to Roche’s supplemental Biologics License Application for Xolair^® (omalizumab) for treatment of children and adults with food allergies.

The drug, a monoclonal antibody, could be used in adults and children over 1 year of age for reduction of allergic reactions, including anaphylaxis, that may occur following accidental exposure to one or more foods.

“Despite the significant and growing health burden from food allergies, treatment advances have been limited,” said Levi Garraway, Roche’s Chief Medical Officer and Head of Global Product Development.

“The FDA’s Priority Review designation acknowledges the unmet need for these patients, and we hope to make Xolair available to as many people as possible living with food allergies in the US,” Garraway added.

FDA’s priory review was based on positive results from an ongoing Phase III clinical trial, OUtMATCH, sponsored by the US National Institutes of Health (NIH).

The study involves patients aged 1 to 55 years who are allergic to peanuts and at least two other common foods. It is being conducted by the NIAID-funded Consortium of Food Allergy Research (CoFAR) across 10 clinical sites throughout the US.

During Stage 1 of the trial, patients were randomised to receive placebo or Xolair injections either every two weeks or every four weeks for 16 to 20 weeks.

Interim results from the first 165 participants in the study showed Xolair “significantly increased the amount of peanut, milk, egg and cashew it took to cause an allergic reaction.”

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

The FDA is expected to decide on approval of Xolair for patients with food allergies in the first quarter of 2024. The drug is being developed and co-promote by Genentech (part of the Roche Group) and Novartis Pharmaceuticals Corporation in the United States.

How omalizumab works

Omalizumab is the only approved antibody designed to target and block immunoglobulin E (IgE). Produced in large quantities in patients with allergies, IgE triggers an allergic reaction in response to an allergen. By attaching to IgE, omalizumab reduces the free IgE in the blood, down-regulating high-affinity IgE receptors and limiting mast cell degranulation, minimising the release of mediators throughout the allergic inflammatory cascade.

Xolair (omalizumab) is currently approved by the FDA, the European Medicines Agency (EMA) and other regulators for the treatment of moderate to severe persistent allergic asthma, chronic spontaneous urticaria and chronic rhinosinusitis with nasal polyps.

If approved by the FDA for food allergies, people taking Xolair would still need to avoid foods they are allergic to.