Omalizumab: clinical trials recruiting now

FDA drug label

FDA-approved

Yes. Omalizumab appears in the FDA drug-label database. Marketed as XOLAIR, Xolair PFS, Xolair.

Drug class

Anti-IgE (FDA established pharmacologic class)

Mechanism of action

IgE-directed Antibody Interactions (as stated on the FDA label)

Boxed warning

The FDA label for Omalizumab carries a boxed warning (the FDA's most serious warning). See the full label for details.

FDA-approved use

XOLAIR is an anti-IgE antibody indicated for: Moderate to severe persistent asthma in adults and pediatric patients 6 years of age and older with a positive skin test or in vitro reactivity to a perennial aeroallergen and symptoms that are inadequately controlled with inhaled corticosteroids ( 1.1 ) Chronic rhinosinusitis with nasal polyps (CRSwNP) in adult patients 18 years of age and older with inadequate response to nasal corticosteroids, as add-on maintenance treatment ( 1.2 ) IgE-mediated food allergy in adult and pediatric patients aged 1 year and older for the reduction of allergic reactions (Type I), including anaphylaxis, that may occur with accidental exposure to one or more foods. To be used in conjunction with food allergen avoidance ( 1.3 ) Chronic spontaneous urticaria (CSU) in adults and adolescents 12 years of age and older who remain symptomatic despite H1 antihistamine treatment ( 1.4 ) Limitations of Use : Not indicated for acute bronchospasm or status asthmaticus. ( 1.1 , 5.3 ) Not indicated for the emergency treatment of allergic reactions, including anaphylaxis ( 1.3 ) Not indicated for other forms of urticaria. ( 1.4 ) 1.1 Asthma XOLAIR is indicated for adult…

FDA label via openFDA