What's Happening?
AstraZeneca's efforts to gain approval for its respiratory drug Fasenra in treating chronic obstructive pulmonary disease (COPD) have been unsuccessful following a negative outcome in the phase 3 RESOLUTE trial. The trial aimed to demonstrate the efficacy of Fasenra, an IL-5 inhibitor, in reducing COPD exacerbations compared to a placebo. Despite some improvements, the results were not statistically significant, leading AstraZeneca to halt its pursuit of regulatory approval for this indication. This marks the end of a challenging journey for AstraZeneca, which had previously faced setbacks with the GALATHEA and TERRANOVA studies in 2018. Fasenra, launched in 2017, is already approved for severe eosinophilic asthma and eosinophilic granulomatosis with polyangiitis, and is under review for hypereosinophilic syndrome. The drug is AstraZeneca's second largest respiratory product, generating $920 million in sales in the first half of the year.
Why It's Important?
The failure to secure approval for Fasenra in COPD represents a significant missed opportunity for AstraZeneca in a rapidly growing market. COPD is the third leading cause of death globally, affecting over 300 million people, with a substantial portion of patients potentially benefiting from biologic treatments like Fasenra. The market for COPD therapies is projected to expand significantly, with sales expected to rise from $11.6 billion in 2023 to over $30 billion by 2033. Competitors such as GSK and Sanofi/Regeneron have already secured approvals for their biologics, Nucala and Dupixent, respectively, positioning them to capture a larger share of this lucrative market. AstraZeneca's inability to join this group could impact its competitive standing and revenue potential in the respiratory drug sector.
What's Next?
AstraZeneca plans to shift its focus to other candidates in its pipeline for COPD treatment following the setback with Fasenra. Meanwhile, the company has reported positive results from a phase 3 trial of a new subcutaneous formulation of Saphnelo for systemic lupus erythematosus (SLE), which could offer a new treatment option for patients. AstraZeneca is working with regulatory authorities to bring this new formulation to market, potentially expanding its presence in the SLE treatment landscape. The company aims to establish remission as a treatment goal for more SLE patients, leveraging the success of the intravenous version of Saphnelo, which has been on the market since 2022.
