Company: AZN
Filing Date: 2025-09-17
Form Type: 6-K
Source: 0001654954-25-010845
Chunk: 1

Company: ASTRAZENECA PLC
Filing Date: 2025-09-17
Form: 6-K
Chunk 1
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asenra has helped transform treatment of severe asthma, and more recently has demonstrated a significant effect in eosinophilic granulomatosis with polyangiitis and hypereosinophilic syndrome."

The safety and tolerability profile for Fasenra in the trial was consistent with the known profile of the medicine. 1 The Company will analyse the full data set from RESOLUTE to further understand the results, which will be shared with the scientific community in the future.

Fasenra is currently approved as an add-on maintenance treatment for severe eosinophilic asthma (SEA) in more than 80 countries, including the US, Japan, EU and China. 2-5 It is also approved for SEA in children and adolescents ages six and above in the US and Japan. 6 Fasenra is also approved in more than 60 countries for the adult treatment of eosinophilic granulomatosis with polyangiitis (EGPA), 7 and is under regulatory review for the treatment of hypereosinophilic syndrome (HES).

#### Notes

#### COPD
COPD is a debilitating, irreversible and progressive disease. 8-11 COPD exacerbations are life-threatening and accelerate disease progression, irreversible lung damage, increased hospitalisations, subsequent exacerbations and death. 8-12 COPD is one of the most common chronic respiratory diseases, affecting 391 million people globally, 8 and is among the highest causes of morbidity and mortality globally. 13

#### RESOLUTE
RESOLUTE is a randomised, double-blind, placebo-controlled Phase III trial to evaluate the efficacy and safety of benralizumab 100 mg in people with moderate to very severe COPD with a history of frequent COPD exacerbations and an elevated blood eosinophil count (BEC) ≥ 300 cells/µL. 1,4 Participants in the trial had a history of at least two COPD exacerbations in the year prior to enrolment, were on background treatment with ICS/LABA/LAMA and were a current or former smoker. 14 The primary endpoint was the annualised rate of moderate or severe exacerbations in patients with three or more exacerbations in the previous year. The RESOLUTE trial population was informed by the analysis from the Phase III GALATHEA and TERRANOVA trials.

Participants (n=689) were randomised to receive placebo-solution or Fasenra (100 mg every four weeks for the first three doses and then