Amgen, Inc. (NASDAQ:AMGN) has announced the results of its recent cardiovascular outcomes study on Repatha which is also known as evolocumab.
The company stated in its announcement that the new analysis of the Repatha cardiovascular outcomes study demonstrated a noteworthy relationship between lower cardiovascular event rates and lower achieved low-density lipoprotein cholesterol (LDL-C) levels. This finding was made in patients suffering from atherosclerotic cardiovascular disease. The study did not show any evidence of a levelling off effect and the analysis also identified safety concerns. The company presented the results of the study during a Late-Breaking Clinical Trials session that was held at the European Society of Cardiology (ESC) Congress 2017 in Barcelona.
“With this analysis, we’ve further demonstrated the safety and efficacy of achieving an LDL-C well below current targets,” stated Robert P. Giugliano, M.D., S.M., Brigham and Women’s Hospital and Harvard Medical School, Boston who was the lead author of the study.
Dr. Giugliano also pointed out that the findings from the initial study involving a large number of patients aimed to achieve ultra-low LDL-C levels. This will support intensive lipid-lowering therapies including a combination of statin therapy and evolocumab in cases where patients are in critical condition. He added that this will help lower the risk of another cardiovascular event.
The company has been carrying out the Repatha cardiovascular outcomes study for a median of 2.2 years with 26,000 patients participating in the study. The patients were divided into five groups for post-randomization. Amgen reported a highly significant progressive relationship between lower LDL-C and a lower risk of the primary composite endpoint.
It also reported that there was no significant difference in the safety profile throughout the five groups. The study also highlighted that patients were more likely to register very low LDL-C levels when they were treated with a combination of statin therapy and Repatha, rather than when the regimen only involved statin. Sean E. Harper, Amgen’s president of research and development stated that the scientific evidence demonstrating the strong association between the risk reduction of cardiovascular events and lowering LDL-C in atherosclerotic cardiovascular disease patients continues to grow.
Amgen stock closed the latest trading session on Monday at $171.78.