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 welcomed the news. The chief medical officer and head of global product development for Genentech, the maker of Xolair, noted that there are not yet any FDA-approved food allergy treatments. “We are committed to helping address this high unmet medical need,” she said. [Update: In 2020, the FDA did approve Palforzia as the first food allergy therapy. It targets peanut allergy.]
Horning added that Genentech looks 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.”
Genentech Cites Data Strength
Omalizumab is currently used to treat moderate to severe persistent allergic asthma that is not controlled by corticosteroid drugs. The injectable treatment is known as an “anti-IgE” biological medication, since it neutralizes free-roaming IgE antibodies. Those are the antibodies 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. It will assess the effectiveness and safety of omalizumab in multiple food allergies.
Read the news release here.
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