Evidence Generation Plan for Benralizumab for Eosinophilic Chronic Obstructive Pulmonary Disease (COPD) to Ensure Market Access in the United States

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Publication Date

11-18-2025

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Presentation: 23:32

Abstract

Chronic obstructive pulmonary disease (COPD) is a heterogeneous, progressive pulmonary disease with frequent exacerbations, rising economic burden, and substantial mortality. A sizable subgroup of COPD patients exhibits eosinophilic inflammation associated with higher exacerbation risk and potentially greater benefit from biologics. Benralizumab is an interleukin-5 receptor antagonist approved for treatment of eosinophilic asthma and eosinophilic granulomatosis with polyangiitis. It is under investigation for the treatment of eosinophilic COPD. The purpose of this capstone was to develop a strategic, US-focused evidence generation plan for benralizumab in eosinophilic COPD across pre-launch, launch, and post-launch phases. Methods included a targeted literature review that identified 52 publications (reviews, meta-analyses, clinical, and real-world evidence publications) focused on eosinophilic COPD; a gap identification on patient experience, treatment patterns, and healthcare utilization; and the creation of an integrated evidence generation plan. Elements of the evidence generation plan included randomized clinical trials (RCTs), real-world studies, and health economic modeling. The pre-launch plan specified RCT endpoints including annualized COPD exacerbation rate, pre-bronchodilator forced expiratory volume, quality of life, and safety. It is complemented by real-world database studies on the US COPD patient journey, COPD triple therapy utilization disparities, and specialist/pulmonologist utilization, as well as cost-effectiveness modeling and payer-perspective budget impact analyses. Post-launch plans included real-world effectiveness, health care resource utilization, and cost studies and network meta-analyses. Unfortunately, in September 2025 it was announced that benralizumab’s Phase III RESOLUTE trial did not meet its primary endpoint, leading to termination of benralizumab’s development for COPD. A rigorous, multi-pronged evidence strategy is essential for regulatory approval, market access, payer reimbursement, and clinical adoption, and although benralizumab’s COPD development program has ceased, the generated framework, trial results, and planned real-world studies can inform payer decisions, optimize current COPD therapies, and guide future biologic development and differentiation in COPD.

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English

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