Therapeutic indication (EU) |
Omalizumab is indicated as add-on therapy to improve asthma control in adult and adolescent patients (≥12 yrs of age) with severe persistent allergic asthma who have the following characteristics: |
A positive skin test or in vitro reactivity to a perennial allergen |
Reduced lung function (FEV1 <80%) |
Frequent daytime symptoms or night-time awakenings |
Multiple documented severe asthma exacerbations |
Receiving daily high-dose ICS and a LABA |
Omalizumab treatment should only be considered for patients with convincing IgE-mediated asthma |
Treatment should be initiated by physicians experienced in the diagnosis and treatment of severe persistent asthma |
Evaluating response |
16 weeks after commencing omalizumab therapy, patients should be assessed by their physician for treatment effectiveness before further injections are administered. The decision to continue omalizumab therapy should be based on whether a marked improvement in overall asthma control is achieved |