Biologics License Application for Xolair Granted FDA Priority Review for Food Allergies

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The FDA has granted Priority Review to Genentech's supplemental Biologics License Application (sBLA) for Xolair (omalizumab) for the treatment of allergic reactions, such as anaphylaxis, that may result from an accidental exposure to one or more foods in patients aged 1 year and older with a food allergy.¹ If the FDA approves the application, Xolair would be the first drug indicated to lower allergic reactions to multiple foods after an accidental exposure. Roche said it expects the FDA to decide on the approval in the first quarter of 2024.

“Despite the significant and growing health burden from food allergies, treatment advances have been limited,” said Levi Garraway, MD, PhD, Genentech's chief medical officer and head of Global Product Development.¹ “We are proud to partner with the National Institutes of Health and leading research institutions on this groundbreaking study. 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.”

If the FDA approves the sBLA, patients taking Xolair would still need to avoid the foods they are allergic to. Genentech and Novartis Pharmaceuticals Corporation collaborated to develop and co-promote Xolair in the United States.

Xolair is a monoclonal antibody that binds to and inhibits immunoglobulin E (IgE). IgE is involved in the pathophysiology of the allergic inflammation characteristic of asthma.² Through this mechanism of action, IgE down-regulates the immune response to help gain control over allergy-driven inflammation.

The acceptance of the sBLA was based on a positive interim analysis of data by an independent Data and Safety Monitoring Board (DSMB) from stage one of the National Institutes of Health-sponsored pivotal three-stage, multicenter, randomized, double-blind, placebo-controlled Phase III OUtMATCH trial (NCT03881696). The study analyzed Xolair in patients allergic to peanuts and at least two other common foods. The DSMB analyzed data from the first 165 patients aged 1 to 17 years who participated in the first stage of the trial, which showed the study achieved its primary endpoint and key secondary endpoints.

Compared with placebo, Xolair was found to significantly increase the amount of peanuts—the trial’s primary endpoint—and milk, egg, and cashew—the trial’s key secondary endpoints—that it takes to trigger an allergic reaction in participants with food allergies. In terms of safety, adverse events were consistent with the previously established benefit-risk profile of Xolair for its approved indications in prior clinical trials.

OUtMATCH was sponsored and funded by the National Institute of Allergy and Infectious Diseases, supported by Genentech and Novartis, and conducted by the Consortium of Food Allergy Research across 10 clinical sites throughout the United States. OUtMATCH analyzed the safety and efficacy of Xolair in patients from 1 to 55 years of age with allergy to peanuts and at least two other common foods. To date, only stage one of the trial has been completed.

Patients in this stage were randomly assigned to receive placebo or Xolair injections either every two weeks or every four weeks for 16 to 20 weeks. The drug’s dose and dosing interval were determined by total serum IgE level and body weight.

The FDA granted Xolair with Breakthrough Therapy Designation in August 2018 to prevent severe allergic reactions after accidental exposure to one or more foods in people with allergies. Xolair is currently approved to treat moderate to severe persistent allergic asthma, chronic spontaneous urticaria, and chronic rhinosinusitis with nasal polyps.

References

1. FDA Grants Priority Review to Xolair (omalizumab) for Children and Adults With Food Allergies Based on Positive National Institutes of Health Phase III Study Results. Genentech. News release. December 19, 2023. Accessed December 20, 2023. https://www.gene.com/media/press-releases/15016/2023-12-19/fda-grants-priority-review-to-xolair-oma

2. Delimpoura V, Bonstantzoglou C, Liu N, Nenna R. Novel therapies for severe asthma in children and adults. Breathe (Sheff). 2018 Mar;14(1):59-62. Accessed December 20, 2023.