AstraZeneca announced new data from the Phase 3 BORA trial evaluating the long-term safety and efficacy of Fasenra (benralizumab) as add-on maintenance therapy in patients with severe eosinophilic asthma who had previously completed one of the two pivotal SIROCCO or CALIMA Phase 3 trials. The data was presented at a late-breaking oral session at the European Respiratory Society International Congress 2018.
Results from the extension trial showed a similar safety and tolerability profile for Fasenra as that seen in SIROCCO and CALIMA. In addition, improvements in efficacy outcomes in the SIROCCO/CALIMA trial were maintained over the second year of treatment. Specifically, 74% of patients with blood eosinophil ≥300 cells/µL who received Fasenra every 8 weeks from SIROCCO/CALIMA into BORA were exacerbation-free in year 2 of treatment. Moreover, improvements in lung function and asthma control were maintained.
Additional data indicated that near complete eosinophil depletion was maintained in patients who continued to receive Fasenra. Upper respiratory tract infection, worsening asthma, headache, bronchitis, and acute sinusitis were the most commonly reported adverse events in BORA.
Fasenra, an interleukin-5 antagonist, is currently approved as add-on maintenance treatment of severe asthma in patients aged ≥12 years, and with an eosinophilic phenotype. It is supplied as 30mg/mL strength subcutaneous injections in single-dose prefilled syringes.
For more information visit Fasenra.com.