Omalizumab

Therapeutic indications

Omalizumab is indicated for:

Allergic asthma

Population group: only adolescents (12 years - 18 years old) , adults (18 years old or older)

Omalizumab is indicated in adults, adolescents and children (6 to <12 years of age).

Omalizumab treatment should only be considered for patients with convincing IgE (immunoglobulin E) mediated asthma.

Adults and adolescents (12 years of age and older)

Omalizumab is indicated as add-on therapy to improve asthma control in patients with severe persistent allergic asthma who have a positive skin test or in vitro reactivity to a perennial aeroallergen and who have reduced lung function (FEV1 <80%) as well as 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.

Children (6 to <12 years of age)

Omalizumab is indicated as add-on therapy to improve asthma control in patients with severe persistent allergic asthma who have a positive skin test or in vitro reactivity to a perennial aeroallergen and 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.

For this indication, competent medicine agencies globally authorize below treatments (click for details):

Chronic spontaneous urticaria (CSU)

Population group: only adolescents (12 years - 18 years old) , adults (18 years old or older)

Omalizumab is indicated as add-on therapy for the treatment of chronic spontaneous urticaria in adult and adolescent (12 years and above) patients with inadequate response to H1 antihistamine treatment.

For this indication, competent medicine agencies globally authorize below treatments (click for details):

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