AstraZeneca is making another push to get its biologic drug Fasenra approved for chronic obstructive pulmonary disease (COPD), this time with a more targeted approach focusing on patients with elevated eosinophil levels. This renewed effort follows the recent FDA approval of Fasenra for eosinophilic granulomatosis with polyangiitis (EGPA), a rare respiratory disease, and aims to expand the drug's reach in the respiratory arena.
Precision Medicine in Respiratory Care
Dr. Donna Carstens, senior medical director for Fasenra at AstraZeneca, highlighted the evolution of respiratory disease treatment from a "treat-to-fail" to a "treat-to-target" approach. This shift allows clinicians to identify patients with specific treatable traits and tailor treatments accordingly, leading to more impactful outcomes. The annual updates to guidelines such as the GOLD guidelines for COPD and the GINA report for asthma play a crucial role in helping clinicians adopt an unbiased approach to disease management.
Fasenra's Journey and EGPA Approval
Fasenra, initially approved in 2017 for severe eosinophilic asthma, recently gained approval for EGPA after demonstrating superiority over GSK’s Nucala in a head-to-head study. This approval underscores Fasenra's ability to effectively target eosinophils, white blood cells that, when present in high levels, cause inflammation and contribute to various respiratory conditions. According to Dr. Carstens, the EGPA approval highlights Fasenra’s dexterity in treating eosinophil-driven respiratory conditions.
COPD Trials and Future Prospects
Despite its successes, Fasenra faced setbacks in 2018 when it failed to meet endpoints in two late-stage COPD trials. AstraZeneca is now conducting a Phase 3 trial in COPD, selectively enrolling patients with higher eosinophil counts to better align with Fasenra's mechanism of action. The ongoing study, which has completed enrollment and anticipates results next year, aims for a potential approval in 2026. Carstens noted that the previous trials helped the company better understand the disease and identify the patient population most likely to benefit from Fasenra.
Overcoming Challenges in COPD
According to Carstens, the key to success in COPD lies in identifying patients with an eosinophilic phenotype. The company's ongoing study enriches for a population of 300 and greater eosinophils, a severe population where this is add-on therapy. This targeted approach, combined with lessons learned from earlier trials, positions AstraZeneca with a higher confidence level for Fasenra in COPD. The evolution of medicine and the availability of drugs like Fasenra have enabled researchers to recognize the significant impact of eosinophilia in COPD patients, leading to more focused and effective treatment strategies.
