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Diseases

AstraZeneca's Fasenra Trial Falls Short in COPD Treatment

Strategic Insights

— 1 min read

AstraZeneca's flagship treatment, Fasenra (benralizumab), has shown promise in treating various respiratory diseases, but its latest trial, RESOLUTE, failed to demonstrate statistical significance in treating chronic obstructive pulmonary disease (COPD). The trial showed numerical improvement, but the results were not enough to meet the primary endpoint. Despite this setback, the company remains optimistic, citing Fasenra's proven track record in other areas, such as severe asthma, eosinophilic granulomatosis with polyangiitis, and hypereosinophilic syndrome.

Key Takeaways:

  • The RESOLUTE Phase III trial of AstraZeneca's Fasenra (benralizumab) did not achieve statistical significance in the primary endpoint for treating chronic obstructive pulmonary disease (COPD).
  • The trial showed numerical improvement in patients with COPD, but the results were not sufficient to meet the primary endpoint.
  • Fasenra has shown promise in treating other respiratory diseases, including severe asthma, eosinophilic granulomatosis with polyangiitis, and hypereosinophilic syndrome.
  • The safety and tolerability profile of Fasenra in the RESOLUTE trial was consistent with its known profile.
  • The company will analyze the full data set from RESOLUTE to better understand the results.
  • Fasenra is approved as an add-on maintenance treatment for severe eosinophilic asthma (SEA) in more than 80 countries, including the US, Japan, EU, and China.
  • It is also approved for SEA in children and adolescents ages six and above in the US and Japan.
  • Fasenra is approved in more than 60 countries for the adult treatment of eosinophilic granulomatosis with polyangiitis (EGPA).

Statistics:

  • The RESOLUTE trial consisted of patients with moderate to very severe COPD.
  • Fasenra is approved in over 80 countries, including the US, Japan, EU, and China.
  • The treatment is approved for SEA in children and adolescents ages six and above in the US and Japan.
  • Fasenra is also approved in more than 60 countries for the treatment of eosinophilic granulomatosis with polyangiitis (EGPA).

Sources:

  • AstraZeneca Press Release [press release]
  • Fasenra Website, "Fasenra prescribing information" [1]
  • Fasenra Website, "Fasenra for SEA (inflammation) in adults and children" [2]
  • Fasenra Website, "Fasenra for SEA (inflammation) in children and adolescents" [3]
  • Fasenra Website, "Fasenra for SEA (inflammation) in Japan" [4]
  • Fasenra Website, "Fasenra for SEA (inflammation) in the US" [5]
  • Fasenra Website, "Fasenra for EGPA (inflammation) in adults" [6]
  • Fasenra Website, "Fasenra for HES (inflammation) under regulatory review" [7]

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