The FDA has approved Bayer’s asundexian (Sunharbo) for secondary stroke prevention in people who recently had a mild-to-moderate non-cardioembolic ischemic stroke or a high-risk transient ischemic attack. The pivotal Phase 3 study reported a 26% reduction in ischemic stroke risk versus placebo, with similar rates of major bleeding and diarrhea as the most frequent adverse reaction. In parallel, the FDA ordered a class-wide label update for all approved GLP-1 receptor agonists, requiring inclusion of potential increased risk of non-arteritic anterior ischemic optic neuropathy (NAION). The agency cited a meta-analysis of 126 clinical trials and concluded the class may carry a higher NAION incidence signal versus comparators, prompting warnings and precautions rather than an indication restriction.