AstraZeneca Fasenra Trial Misses in COPD

AstraZeneca says its RESOLUTE Phase 3 trial of Fasenra (benralizumab), despite showing numerical improvement, did not achieve the primary endpoint in patients with chronic obstructive pulmonary disease (COPD). Fasenra (benralizumab) is currently approved in the U.S. for two eosinophil-driven conditions: severe eosinophilic asthma and eosinophilic granulomatosis with polyangiitis.

The safety and tolerability profile for Fasenra in the trial was consistent with the drug’s known profile, according to the company. It says data will be further analyzed to further understand the results.

AstraZeneca says RESOLUTE enrolled participants who had a history of at least two COPD exacerbations in the prior year. The primary endpoint was a reduction in the annualized rate of moderate or severe exacerbations in patients with three or more exacerbations in the previous year, it says.