FDA Grants Breakthrough Designation to Omalizumab for Food Allergies

AUGUST 13, 2018
Kevin Kunzmann
The FDA has granted Breakthrough Therapy designation to omalizumab (Xolair, Genentech), a subcutaneous injection therapy indicated for atopic conditions which could become the first treatment approved for the prevention of severe food allergy reactions.

Omalizumab was granted the designation to expedite its regulatory development and review as a potential therapy for serious or life-threatening conditions. The designation was based on data from 7 clinical trials over the past decade, which assessed omalizumab’s efficacy and safety versus various food allergens, such as peanut, milk, and egg.

The trials, which assessed omalizumab as both a monotherapy or in combination with oral immunotherapy, were supported by both Genentech and individual sponsors, such as the National Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health (NIH). Genentech and Novartis Pharmaceuticals are currently working with the NIAID and the Consortium of Food Allergy Research to launch a potentially pivotal study assessing the efficacy and safety of omalizumab in multiple food allergies, with details coming at a later date.

Omalizumab was previously approved by the FDA to treat moderate to severe persistent asthma in patients aged 6 years or older whose asthma symptoms are not controlled by inhaled corticosteroids, as well as chronic idiopathic urticaria in patients 12 years and older who continue to have hives that are not controlled by H1 antihistamine treatment.

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