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.
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.
This Week's Must Reads
AHA Statement: Accurate Measurement of BP, Hypertension; ePub 2019 Mar 4; Muntner, et al
Coffee Consumption & Plasma Biomarkers, Am J Clin Nutr; ePub 2019 Mar 5; Hang, et al
Is Adding Aspirin to Warfarin Therapy Beneficial? , JAMA Intern Med; ePub 2019 Mar 4; Schaefer, et al
Urinary Oxalate Excretion & Risk of CKD Progression, JAMA Intern Med; ePub 2019 Mar 4; Waikar, et al
Psychosocial Stress & CV Health in Older Women, Circulation; ePub 2019 Feb 28; Burroughs-Peña, et al
Must Reads in FDA Actions
FDA Approves Steglatro for Adults with T2D, Pfizer news release; 2017 Dec 22
FDA Approves Ozempic for Treatment of T2D, Novo Nordisk news release; 2017 Dec 5
FDA Approves Epinephrine Autoinjector for Infants, Kaléo news release; 2017 Nov 20
FDA Approves Fasenra for Severe Eosinophilic Asthma, AstraZeneca news release; 2017 Nov 14
Shingrix Approved for Prevention of Shingles, GSK news release; 2017 Oct 23