Table 1.

Licensed therapeutic indication of omalizumab for pediatric age

US Food and Drug Administration [6]	European Medicines Agency [7]
Pediatric allergic asthma
Omalizumab is indicated for adolescents (aged ≥12 years) with moderate to severe persistent asthma who have a positive skin test or in vitro reactivity (blood test) to a perennial aeroallergen and whose symptoms are inadequately controlled with inhaled corticosteroids  Limitations of use: omalizumab is not indicated for the relief of acute bronchospasm or status asthmaticus; omalizumab is not indicated for treatment of other allergic conditions	Omalizumab is indicated as add-on therapy to improve asthma control in adolescents (aged ≥12 years) and children (aged 6 to <12 years) with severe persistent allergic asthma who have a positive skin test or in vitro reactivity (blood test) to a perennial aeroallergen and who have frequent daytime symptoms or night-time awakenings and who have had multiple documented severe asthma exacerbations despite daily high-dose inhaled corticosteroids, plus a long-acting inhaled beta2-agonist. Patients aged ≥12 years must also have reduced lung function (FEV1 <80 % of normal)
Chronic spontaneous urticaria
Omalizumab is indicated for the treatment of adolescents (aged ≥12 years) with chronic idiopathic urticaria who remain symptomatic despite H1 antihistamine treatment  Limitation of use: omalizumab is not indicated for the treatment of other forms of urticaria	Omalizumab is indicated as add-on therapy for the treatment of chronic spontaneous urticaria in adolescent (aged ≥12 years) patients with inadequate response to H1 antihistamine treatment

FEV ₁ forced expiratory volume in 1 s