AstraZeneca’s Fasenra (benralizumab) recently received Food and Drug Administration (FDA) approval for severe asthma in children aged 6 to 11, specifically for the eosinophilic phenotype, in over 80 countries, including the US, EU, and Japan. Fasenra is a monoclonal antibody intended to inhibit the alpha subunit of the interleukin-5 receptor found on eosinophils and is currently a Phase III clinical trial agent for chronic obstructive pulmonary disease (COPD) treatment. A current gap in the COPD market is the absence of biologics, however, Fasenra has the potential to address this gap, says GlobalData, a leading data and analytics company.

According to GlobalData’s Sales and Forecast database, total sales for Fasenra are forecast to reach $2.0 billion globally by 2029. AstraZeneca’s Fasenra is one of the six late-stage biologics being developed for COPD, alongside its tozorakimab (Phase III) and Tezspire (Phase II).

Asiyah Nawab, Pharma Analyst at GlobalData, comments: “Therapies for COPD have been in development for decades to reduce exacerbations and manage the symptom load of the disease, with a greater shift in the development of biologics.  Although Fasenra has been approved for severe eosinophilic asthma, it has encountered a tough journey in meeting the primary endpoints of clinical trials for COPD.”

Fasenra underwent two Phase III clinical trials in 2018, GALATHEA and TERRANOVA, for moderate to very severe COPD. Unfortunately, both clinical trials were unable to meet their primary efficacy endpoint.

Nawab continues: “Although the data from the GALATHEA and TERRANOVA clinical trials did not reach their primary endpoint, AstraZeneca was able to supplement further clinical studies by providing insights on elevated blood eosinophil count combined with the clinical characteristics of COPD patients that could benefit from Fasenra. This has led to the initiation of the Phase III RESOLUTE clinical trial, which has recruited over 600 patients presenting with a history of frequent COPD exacerbations and elevated peripheral blood eosinophils, and is expected to end in June 2025.”

The RESOLUTE trial evaluates the efficacy and safety of the biologic in moderate to very severe COPD patients who present with frequent exacerbations. The study is categorized into two arms, with the first consisting of the administration of the biologic subcutaneously every four weeks for the first three doses, thereafter, every eight weeks until the end of the treatment. The second arm of the study involves a placebo comparator, taken alongside the same timeframe as the experimental biologic.

Interviews with Key Opinion Leaders (KOLs) as part of GlobalData research have expressed mixed opinions about Fasenra, stating that the biologic only targets eosinophils, and targeting eosinophils simply does not seem to be enough in the treatment of COPD.

Other KOLs interviewed by GlobalData have expressed that AstraZeneca’s current late-stage pipeline for COPD is one to watch, expressing a great deal of interest in them.

Nawab concludes: “Despite the mixed views of Fasenra as a biologic for the treatment of COPD, it may be advantageous as a maintenance therapy for COPD patients if approved. However, AstraZeneca’s close competitor, Regeneron/Sanofi’s Dupixent has the potential to dominate the market if the biologic receives approval following the FDA’s decision, which is expected to be announced in June 2024. At present, the COPD late-stage pipeline looks promising, representing a new age of therapies and one to keep an eye on.”