The FDA has given its “breakthrough therapy designation” to omalizumab, known by the brand Xolair, to be developed as a potential food allergy treatment.
Dr. Sandra Horning, chief medical officer and head of global product development of Genentech, the maker of Xolair, notes that there are not yet any FDA-approved food allergy treatments. “We are committed to helping address this high unmet medical need and look forward to working with leaders in the field to further develop Xolair as a potential medicine to help people with this condition that can be life-threatening,” she said.
Omalizumab is currently used to treat moderate to severe persistent asthma that has an allergic basis and is not adequately controlled by inhaled corticosteroid drugs. The injectable treatment is known as an “anti-IgE” biological medication, since it neutralizes free-roaming IgE antibodies – those that set off allergic symptoms.
In a news release, the company said the “breakthrough” status was granted on the strength of data “from seven clinical studies over the last decade assessing the efficacy and safety of Xolair against a range of food allergens including peanut, milk, egg and others.”
The studies have been both of omalizumab as a solo therapy or in combination with oral immunotherapy (OIT), and received funding from National Institute of Allergy and Infectious Diseases (NIAID).
Genetech, NIAID and the Consortium of Food Allergy Research are now working toward a major clinical research study on the effectiveness and safety of the drug in multiple food allergies.
Read the news release here.
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