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ARTICLE | Clinical News

Benralizumab: Phase III data

May 23, 2016 7:00 AM UTC

Top-line data from the double-blind, international Phase III CALIMA trial in 1,306 patients ages >=12 with severe uncontrolled asthma showed that subcutaneous benralizumab for 52 weeks as an add-on to high-dose inhaled corticosteroids plus a long-acting adrenergic receptor beta 2 ( ADRB2) agonist (LABA) with or without oral corticosteroids and additional asthma controllers met the primary endpoint of reducing annual asthma exacerbation rate vs. placebo. Patients received placebo, 30 mg subcutaneous benralizumab every 4 weeks or 30 mg subcutaneous benralizumab every 4 weeks for the first 3 doses followed by 30 mg every 8 weeks. The trial is part of the 6-study Phase III WINDWARD program of benralizumab to treat asthma. Next half, AstraZeneca plans to submit regulatory applications in the U.S. and EU for benralizumab to treat uncontrolled asthma. ...