At a Glance: Asthma Biologics

Omalizumab (Xolair, Novartis/Genentech) 

Initial U.S. approval: 2003 

Indicated for: Moderate to severe persistent allergic asthma in patients 6 years of age or older not controlled by inhaled corticosteroids.

Contraindication: Severe hypersensitivity reaction to Xolair or any ingredient of Xolair.

Black Box Warning: risk of anaphylaxis.

Full Prescribing Information 

Mepolizumab (Nucala, GSK) 

Initial U.S. approval: 2015

Indicated for: Add-on maintenance treatment of patients with severe asthma aged 12 years and older, and with an eosinophilic phenotype.

Contraindications: History of hypersensitivity to mepolizumab or excipients in the formulation

Full Prescribing Information 

Reslizumab (Cinqair, Teva)

Initial U.S. approval: 2016

Indicated for: Add-on maintenance treatment of patients with severe asthma aged 18 years and older, and with an eosinophilic phenotype.  

Contraindication: Known hypersensitivity toreslizumab or any of its excipients.

Black Box Warning: risk of anaphylaxis.

Full Prescribing Information

Dupilumab (Dupixent, Sonofi/Regeneron)

Initial U.S. approval: 2017

Indicated for: Add-on maintenance treatment in patients with moderate-to-severe asthma aged 12 years and older with an eosinophilic phenotype or with oral corticosteroid dependent asthma.

Contraindication: Known hypersensitivity to Dupixent or any of its excipients.

Benralizumab (Fasenra, AstraZeneca)

Initial U.S. approval: 2017

Indicated for: Add-on maintenance treatment of patients with severe asthma aged 12 years and older, and with an eosinophilic phenotype.

Contraindication: Known hypersensitivity to benralizumab or excipients.

Full Prescribing Information