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
TNF inhibitor prices rose despite increased drug class competition, San-Juan-Rodriguez A et al. JAMA Intern Med. 2019 Feb 18. doi: 10.1001/jamainternmed.2018.7656
List of medications linked to drug-induced lupus expands, Arnaud L et al. Ann Rheum Dis. 2019 Feb 4. doi: 10.1136/annrheumdis-2018-214598
HCV-infected patients in the ED should be tested for advanced liver fibrosis, Yu-Hsiang Hsieh Y-H. Am J Emerg Med. 2019;37:286-90
Must Reads in Asthma
Antibiotic Therapy in Patients with Asthma, JAMA Intern Med; ePub 2019 Jan 28; Stefan, et al
Asthma Toolkit Improves Measures of Asthma Care, J Am Board Fam Med; 2019 Jan; Colborn, et al
FDA Approves Fasenra for Severe Eosinophilic Asthma, AstraZeneca news release; 2017 Nov 14
Can Vitamin D Prevent Asthma Exacerbations?, Lancet Respir Med; ePub 2017 Oct 3; Jolliffee, et al
Early-Life Environmental Asthma Risk in Children, J Allergy Clin Immunol; ePub 2017 Sep 19; O’Connor, et al