Regeneron Pharmaceuticals (REGN) and Sanofi (SNY) announced that the Odyssey Outcomes trial met its primary endpoint, showing Praluent Injection “significantly reduced” the risk of major adverse cardiovascular events in patients who had suffered a recent acute coronary syndrome event, such as a heart attack.
Results from the trial will be presented today during a late-breaker session at the American College of Cardiology’s Scientific Session in Orlando, Florida.
Key findings
On the primary endpoint, Praluent reduced the overall risk of MACE by 15%. The MACE composite endpoint includes patients who experienced a heart attack, ischemic stroke, death from coronary heart disease, or unstable angina requiring hospitalization. Praluent was also associated with a lower risk of death overall, known as “all-cause mortality”, and there were also numerically fewer CHD deaths. In a pre-specified analysis, the patients with baseline LDL-C levels at or above 100 mg/dL experienced a more pronounced effect from Praluent, reducing their risk of MACE by 24%.
“This trial was consistent with earlier statin trials, showing the greatest benefit in patients with higher cholesterol levels at baseline,” said George Yancopoulos, MD, PhD, President and Chief Scientific Officer, Regeneron. “Many patients who have survived a recent heart attack or other coronary event are unable to reach an LDL cholesterol goal of less than 100 mg/dL, and have an urgent need for new therapeutic options because of their increased risk of another event. In this trial, such patients who received Praluent on top of maximally-tolerated statins had important reductions in their risk.”
