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Diseases

AstraZeneca's Fasenra Falls Short in RESOLUTE Phase III Trial for Chronic Obstructive Pulmonary Disease (COPD)

Strategic Insights

— 1 min read

AstraZeneca's Fasenra, a treatment for chronic obstructive pulmonary disease (COPD), has failed to meet statistical significance in the primary endpoint of the RESOLUTE Phase III trial. Despite this setback, Fasenra remains a leading treatment for severe eosinophilic asthma (SEA) in over 80 countries, including the US, Japan, EU, and China. The company plans to analyze the full data set from the trial to gain a deeper understanding of the results, which will be shared with the scientific community in the future.

Key Takeaways:

  • AstraZeneca's Fasenra failed to achieve statistical significance in the primary endpoint of the RESOLUTE Phase III trial for COPD.
  • Fasenra is currently approved as an add-on maintenance treatment for SEA in over 80 countries, including the US, Japan, EU, and China.
  • The safety and tolerability profile for Fasenra in the trial was consistent with the known profile of the medicine.
  • The company will analyze the full data set from the RESOLUTE trial to further understand the results.
  • Fasenra has demonstrated a significant effect in eosinophilic granulomatosis with polyangiitis and hypereosinophilic syndrome.
  • The RESOLUTE trial population was informed by the analysis from the Phase III GALATHEA and TERRANOVA trials.
  • The trial enrolled 689 participants, who were randomised to receive either placebo or Fasenra (100 mg every four weeks for the first three doses and then every eight weeks thereafter).
  • The primary endpoint was the annualised rate of moderate or severe exacerbations in patients with three or more exacerbations in the previous year.

Statistics:

  • Over 65 million people suffer from chronic obstructive pulmonary disease (COPD), with 391 million people globally affected. [8-11]
  • COPD exacerbations are life-threatening and accelerate disease progression, irreversible lung damage, increased hospitalisations, subsequent exacerbations, and death. [8-12]
  • Fasenra is currently approved as an add-on maintenance treatment for adults with SEA in more than 80 countries, including the US, Japan, EU, and China. [2-5]
  • The safety and tolerability profile for Fasenra in the trial was consistent with the known profile of the medicine.
  • Over 150,000 patients globally are currently taking Fasenra. [15]

Sources:

  • AstraZeneca. (2025, Sept. 17). Update on RESOLUTE Phase III trial. Retrieved from
  • AstraZeneca. (2025, Sept. 17). RESOLUTE Phase III trial. Retrieved from
  • AstraZeneca. (2025, Sept. 17). Fasenra. Retrieved from

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