Failed pivotal study? You can still have breakthrough therapy status — FDA signals to Resverlogix
A small Canadian biotechnology company has convinced the FDA to reward its sole experimental drug breakthrough therapy status as a preventative therapy for major adverse cardiac events, despite a failed late-stage study.
Last September, Calgary, Alberta-based Resverlogix Corp said its investigational apabetalone did not meet the main pivotal study goal of reducing major adverse cardiovascular events (MACE) — defined as cardiovascular death, non-fatal myocardial infarction, and stroke — when added to standard care in patients with type II diabetes, recent acute coronary syndrome, and low HDL cholesterol.
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