AstraZeneca has recently announced that Fasenra has been approved for severe asthma, specifically for the eosinophilic phenotype, in children aged 6-11 years in more than 80 countries, including the US, EU, and Japan.
Fasenra is a monoclonal antibody that inhibits the alpha subunit of the interleukin-5 receptor found on eosinophils and attracts natural killer cells to induce the near-complete depletion of eosinophils via programmed cell death.
It was first approved in 2017 in the US as an add-on maintenance therapy for the treatment of severe eosinophilic asthma in patients aged 12 years and older and is currently undergoing a Phase III clinical trial for chronic obstructive pulmonary disease (COPD).
According to leading data and analytics company GlobalData’s Sales and Forecast database, total sales for Fasenra are set to reach $2.0bn globally by 2029.
COPD is a heterogeneous, progressive lung disease characterised by chronic symptoms, including dyspnea, cough, sputum production, and/or exacerbations (GOLD, 2022).
Therapies for COPD have been in development for decades to reduce exacerbations and manage the symptom load of the disease, with biologics dominating the late-stage COPD pipeline.
AstraZeneca’s Fasenra is one of the six late-stage biologics currently being developed for COPD, alongside the company’s other pipeline agents, including tozorakimab (Phase III), and Tezspire (Phase II).
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By GlobalData
While Fasenra has been approved for severe eosinophilic asthma, it has encountered difficulties meeting the primary endpoints of clinical trials for COPD.
Prior to the Fasenra RESOLUTE Phase III clinical trial, Fasenra underwent two Phase III clinical trials in 2018, GALATHEA and TERRANOVA, for moderate to severe COPD.
Unfortunately, both clinical trials were unable to meet their primary efficacy endpoints.
This was slightly disappointing, as it could have been one of the first biologics for COPD if it had been approved.
However, data from the 2019 European Respiratory Society International Congress provided additional information on Fasenra, identifying its baseline clinical characterisation with reduced annual rates of moderate and severe COPD exacerbations.
Both the GALATHEA and TERRANOVA clinical trials were able to supplement further clinical studies as they were able to provide insights on elevated blood eosinophil count combined with the clinical characteristics of COPD patients who could benefit from Fasenra.
This has led to the initiation of the Phase III RESOLUTE clinical trial, which has recruited more than 600 patients presenting with a history of frequent COPD exacerbations and elevated peripheral blood eosinophils.
The RESOLUTE trial, which is expected to end in June 2025, is evaluating the efficacy and safety of the biologic in moderate to severe COPD patients who present with frequent exacerbations.
The study is categorised into two arms.
The first arm involves the subcutaneous administration of the biologic every four weeks for the first three doses, and then every eight weeks until the end of the treatment.
The second arm of the study involves a placebo comparator taken for the same timeframe as the experimental biologic.
Key opinion leaders (KOLs) interviewed by GlobalData have expressed mixed opinions about Fasenra, stating that the biologic only targets eosinophils, and targeting eosinophils does not seem to be enough in the treatment of COPD.
As such, targeting interleukin-33 or thymic stromal lymphopoietin (TSLP) pathways may result in better efficacy.
Other KOLs interviewed by GlobalData have expressed a great deal of interest in AstraZeneca’s current late-stage pipeline for COPD, stating that it is one to watch.
After the approval of Fasenra for severe asthma of all ages, and the progression of Fasenra and tozorakimab to Phase III clinical trials for COPD, KOLs have noted their interest in the anti-TSLP and anti-interleukin molecules, being a reason to keep a close eye on them.