Regeneron Pharmaceuticals (NASDAQ:REGN) is up 2% premarket and development partner Sanofi (NYSE:SNY) up a fraction on the heels their announcement of results from the 18,924-subject ODYSSEY OUTCOMES study assessing the impact of Praluent (alirocumab) on the risk of major adverse cardiovascular events (MACE) in patients who experienced a recent acute coronary syndrome (ACS) event, such as a heart attack. The data were presented at the American College of Cardiology Annual Scientific Session & Expo in Orlando, FL.
The trial met the primary endpoint of demonstrating a statistically significant 15% reduction in MACE risk (p=0.0003) compared to placebo. The effect was more pronounced in patients with LDL-C levels at least 100 mg/dL (24%).
Patients receiving Praluent also experienced a statistically valid reduction in the overall risk of death (hazard ratio = 0.85) versus control.
Praluent's impact on the actual number of deaths from coronary heart disease was modest, however, failing to reach statistical significance (p=0.38). This appears to be the main driver behind their plan to discount the medication for high-risk patients.
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