AstraZeneca and MedImmune announced that the Food and Drug Administration (FDA) has approved Fasenra (benralizumab) for the add-on maintenance treatment of patients with severe asthma aged ≥12 years, and with an eosinophilic phenotype.
The approval was supported by data from the phase 3 SIROCCO (Efficacy and Safety Study of Benralizumab Added to High-dose Inhaled Corticosteroid Plus LABA in Patients with Uncontrolled Asthma; ClinicalTrials.gov identifier NCT01928771) and CALIMA (Efficacy and Safety Study of Benralizumab in Adults and Adolescents Inadequately Controlled on Inhaled Corticosteroid Plus Long-acting β-2 Agonist; ClinicalTrials.gov identifier NCT01914757) exacerbation trials, and from the phase 3 oral corticosteroid-sparing trial, ZONDA (Efficacy and Safety Study of Benralizumab to Reduce OCS Use in Patients With Uncontrolled Asthma on High Dose Inhaled Corticosteroid Plus LABA and Chronic OCS Therapy; ClinicalTrials.gov identifier: NCT02075255).
Treatment with Fasenra for 8 weeks in these trials demonstrated up to a 51% reduction in the annual asthma exacerbation rate (AAER) vs placebo. There was also a significant improvement in lung function as measured by forced expiratory volume in 1 second (FEV1) of up to 159 mL vs placebo. Onset of efficacy was seen as early as 4 weeks after the first dose.
Moreover, there was a 75% median reduction in daily oral corticosteroid use and discontinuation of oral corticosteroids in 52% of eligible patients. Phase 2 data demonstrated direct, rapid, and near-completion eosinophil depletion within 24 hours.
Regarding safety, the overall adverse event profile was similar to that seen with placebo. Headache, pyrexia, pharyngitis, and hypersensitivity reactions were among the events reported with an incidence of ≥3%.
Fasenra is an interleukin-5 receptor alpha-directed cytolytic monoclonal antibody (IgG1, kappa). It works by binding to the FcɣRIII receptors on immune effectors cells, such as natural killer (NK) cells, leading to apoptosis of eosinophils and basophils through antibody-dependent cell-mediated cytotoxicity.
Fasenra will be available as a 30 mg/mL strength single-dose prefilled syringe for subcutaneous injection. It is anticipated to launch in the coming weeks.
Fasenra (benralizumab) receives US FDA approval for severe eosinophilic asthma [news release]. Wilmington, DE: AstraZeneca. https://www.astrazeneca.com/media-centre/press-releases/2017/fasenra-benralizumab-receives-us-fda-approval-for-severe-uncontrolled-eosinophilic-asthma-14112017.html. Published November 14, 2017. Accessed November 16, 2017
This article originally appeared on MPR