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FDA Approves Fasenra for Severe Eosinophilic Asthma

AstraZeneca news release; 2017 Nov 14

The US Food and Drug Administration (FDA) has approved Fasenra (benralizumab) for severe eosinophilic asthma. The approval was granted to AstraZeneca (Wilmington, DE).

Indications: Fasenra (benralizumab) is an interleukin-5 receptor alpha-directed cytolytic monoclonal antibody indicated for the add-on maintenance treatment of patients with severe asthma aged ≥12 years, and with an eosinophilic phenotype.

Safety/efficacy: Approval was based on a phase 3 program demonstrating up to a 51% reduction in asthma exacerbations, significant improvement in lung function, and a 75% reduction in daily oral steroid use.

Dosage and administration: Administer by subcutaneous injection. Recommended dose is 30 mg every 4 weeks for the first 3 doses, followed by once every 8 weeks thereafter.

Adverse reactions: Most common adverse reactions (incidence ≥5%) include headache and pharyngitis.

Citation:

Fasenra (benralizumab) receives US FDA approval for severe eosinophilic asthma. [news release]. AstraZeneca; Wilmington, DE. November 14, 2017. https://www.astrazeneca.com/content/astraz/media-centre/press-releases/2.... Accessed November 15, 2017.

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FDA Approves Fasenra for Severe Eosinophilic Asthma, AstraZeneca news release; 2017 Nov 14