AstraZeneca has announced that the results of two trials showed that the new medicine benralizumab has the potential to improve patient outcomes in severe asthma patients.
The SIROCCO and CALIMA clinical trials, part of the comprehensive WINDWARD program in asthma, evaluated the efficacy and safety of two dose regimens of benralizumab as an add-on therapy for severe uncontrolled asthma with eosinophilic inflammation in adults and adolescents aged 12 and older.
The primary populations in the trials were patients on high-dose inhaled corticosteroids (ICS) plus long-acting ?2-agonist (LABA), with a baseline blood eosinophil count ? 300 cells/microliter. The patients were randomized to receive either benralizumab 30mg every 4 weeks, 30mg every 4 weeks for the first three doses followed by 30mg every 8 weeks, or placebo.
“Severe asthma affects the health and quality of life of millions of people around the world, and exacerbations can be life threatening for these patients. We are pleased with the top-line results from these pivotal trials as they demonstrate the potential for benralizumab to improve outcomes for patients with severe asthma,” said Sean Bohen, chief medical officer and executive vice president of Global Medicines Development, in a press release. “Benralizumab is AstraZeneca’s first respiratory biologic and its development underscores our commitment to transform the treatment of asthma and chronic respiratory disease with our next generation of respiratory medicines,”
Benralizumab is also being evaluated in patients with severe COPD in the Phase 3 VOYAGER program.