Phase III study evaluating Repatha (evolocumab) in patients with excess LDL-C meets primary endpoint- Amgen

Amgen has announced positive top-line results from a Phase III study evaluating Repatha (evolocumab) from Amgen, in patients who were receiving apheresis to reduce low-density lipoprotein cholesterol (LDL-C). The study met its primary endpoint, demonstrating that treatment with Repatha significantly reduced the need for LDL-C apheresis in adult patients, as measured at the end of the randomized period.

The study also met its secondary endpoints of percent change from baseline to week 4 in LDL-C, non-high-density lipoprotein cholesterol (non-HDL-C) and total cholesterol:HDL-C ratio. The overall incidence of treatment-emergent adverse events was comparable among both groups. No new safety concerns were identified in this study. Detailed results will be submitted to a future medical conference and for publication.

Comment: Apheresis is an invasive procedure similar to dialysis, in which a special machine removes LDL-C from a patient's plasma. The process can be time consuming and burdensome for patients, as the weekly or bi-weekly treatments can take between one to three hours. Many patients also travel long distances for treatment as there are only approximately 60 apheresis centers in the United States.