AZ planning benralizumab submissions for asthma
AstraZeneca plc (LSE:AZN; NYSE:AZN) said benralizumab ( MEDI-563) met the primary endpoint of significantly reducing annual asthma exacerbation rates vs. placebo in two Phase III studies as an add-on therapy to treat severe uncontrolled asthma with eosinophilic inflammation. The pharma plans to submit U.S. and EU regulatory applications next half for the humanized mAb against interleukin-5 (IL-5) receptor.
The 1,205-patient SIROCCO trial and the 1,306-patient CALIMA trial evaluated two dose regimens of 30 mg benralizumab vs. placebo. The studies enrolled patients aged 12 and older with elevated eosinophil counts, which play a critical role in disease severity and exacerbations. AZ plans to present detailed data at a future medical meeting. ...