HQ Team
September 17, 2025: AstraZeneca’s asthma drug Fasenra (benralizumab) has failed to meet its primary goal in a Phase III trial for chronic obstructive pulmonary disease (COPD), according to a press note from the company.
Despite showing some improvement, the trial did not achieve statistical significance in reducing COPD-related exacerbations in patients with frequent attacks. This marks AstraZeneca’s second setback for Fasenra in treating COPD-related conditions.
The RESOLUTE Trial
The RESOLUTE trial, designed to evaluate Fasenra’s efficacy in reducing COPD exacerbations, involved 689 patients with moderate to severe COPD. Participants had a history of frequent COPD attacks and high levels of eosinophils (a type of white blood cell linked to inflammation). The primary goal of the trial was to reduce the annual rate of moderate or severe exacerbations in patients. While the drug showed some numerical improvement, it did not reach statistical significance in achieving the goal. This means the improvement might have occurred by chance rather than due to the drug’s effectiveness.
COPD
COPD is a progressive lung disease affecting more than 391 million people worldwide. “COPD isn’t just a disease, it’s a relentless cycle,” said Jean Wright, MD, MBA, Chief Executive Officer of the COPD Foundation.
“For individuals living with COPD, managing exacerbations is an ongoing challenge, even with inhaled maintenance therapy. Biologics like mepolizumab are providing renewed optimism for those affected by COPD,” he said.
It causes irreversible lung damage, frequent hospitalizations, and potentially fatal exacerbations. Though Fasenra has been successful in treating severe asthma, its potential to help COPD patients remains unclear after this trial. The results leave room for further analysis, and AstraZeneca plans to share deeper insights with the scientific community in the future.
Despite this setback, Fasenra continues to be approved for severe eosinophilic asthma (SEA) in over 80 countries, including the US, EU, and Japan. It is also approved for treating eosinophilic granulomatosis with polyangiitis (EGPA). AstraZeneca remains optimistic about the drug’s potential in other conditions, such as hypereosinophilic syndrome (HES).
The company’s other treatments for COPD, also known as “smoker’s lung”, include its triple-combination inhaler Breztri Aerosphere, and the experimental tozorakimab.
Sharon Barr, Executive Vice President of BioPharmaceuticals R&D at AstraZeneca, stated, “COPD is a complex disease, and we continue to explore other promising approaches to address unmet patient needs. Fasenra has already transformed the treatment of severe asthma, and we will analyze the full data set from RESOLUTE to further understand the results.”
While these results are disappointing for COPD patients, they do not diminish Fasenra’s proven success in other respiratory conditions.
In related news, the Food and Drug Administration has cleared GSK Plc’s drug for treating patients with inadequately controlled chronic obstructive pulmonary disease (COPD).
