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ARTICLE | Clinical News

AZ not planning regulatory submissions for Fasenra in COPD

May 30, 2018 7:07 PM UTC

AstraZeneca plc (LSE:AZN; NYSE:AZN) said it does not plan to submit regulatory applications for Fasenra benralizumab to treat chronic obstructive pulmonary disease after the drug missed the primary endpoint of reducing exacerbations in a second Phase III trial in the indication.

The 56-week TERRANOVA trial enrolled about 2,255 patients with moderate to very severe COPD with a history of exacerbations across a range of baseline blood eosinophils. Patients received placebo or one of three doses of subcutaneous Fasenra as an add-on to dual or triple inhaled standard of care (SOC). AZ plans to submit the data for presentation at a medical meeting...