This approval extends Fasenra's availability to over 80 countries, including the US, EU, and Japan.
Fasenra, a monoclonal antibody, works by inhibiting the alpha subunit of the interleukin-5 receptor on eosinophils. Currently, Fasenra is also undergoing phase 3 clinical trials for the treatment of chronic obstructive pulmonary disease (COPD).
GlobalData has highlighted a significant gap in the COPD market due to the lack of available biologics, which Fasenra has the potential to fill.
According to the company's sales and forecast database, total sales for Fasenra are forecast to reach $2 billion globally by 2029. AstraZeneca’s Fasenra is one of the six late-stage biologics being developed for COPD by the pharma giant, alongside Tozorakimab in phase 3 and Tezspire in phase 2.
Asiyah Nawab, pharma analyst at GlobalData, said: “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.”
In 2018, Fasenra was evaluated in two phase 3 clinical trials, GALATHEA and TERRANOVA, for moderate to very severe COPD. Unfortunately, neither trial was able to achieve its 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 3 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 is assessing the efficacy and safety of the biologic in patients with moderate to very severe COPD who experience frequent exacerbations.
The study consists of two arms: the first arm administers the biologic subcutaneously every four weeks for the first three doses, followed by every eight weeks for the remainder of the treatment period. The second arm uses a placebo comparator, administered on the same schedule as the 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 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.”
