Off-label applications of omalizumab: Current insights and perspectives

Omalizumab is a humanized monoclonal antibody that binds free IgE. Consequently, it exhibits inhibitory properties against allergic cascades. Over the past 20 years, omalizumab has been in the market, and studies have shown its strong tolerability and safety profile. Since 2003 in the United States of America and 2005 in Europe, omalizumab has been available to patients as a therapeutic option. In Europe, it is registered for the treatment of allergic asthma, chronic spontaneous urticaria, and chronic sinusitis with polyps. In the United States, it has been registered for the treatment of allergic asthma, chronic spontaneous urticaria, and chronic food allergies in children over 1 year of age. With a universal target point for most allergic conditions, omalizumab has the potential to become the most versatile biological drug for allergologists. The literature describes numerous uses of omalizumab as an adjuvant or monotherapy for allergic conjunctivitis, systemic mastocytosis, food allergies, drug hypersensitivity, allergic bronchopulmonary aspergillosis, and allergen immunotherapy, among others. In the following publication, we will provide you with the current knowledge regarding the use of omalizumab in conditions other than those covered by the current product registration.