Biotechnology company Amgen has reported positive top-line results from the Phase III clinical trial of Repatha (evolocumab) for the treatment of patients with low-density lipoprotein cholesterol (LDL-C).
Repatha is a human monoclonal antibody that binds to proprotein convertase subtilisin / kexin type 9 (PCSK9) to prevent it from binding to the low-density lipoprotein receptor (LDLR).
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The results showed that the trial has met both the primary and secondary endpoints.
The randomised Phase III trial evaluated Repatha subcutaneously in patients who were receiving apheresis to minimise LDL-C.
Similar to dialysis, apheresis is an invasive procedure involving the use of a special machine to remove LDL-C from a patient's plasma.
Amgen research and development executive vice-president Sean Harper said: "Patients who require apheresis to help control their LDL-C have limited treatment options and face the daunting challenge of frequent, invasive and costly procedures.
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By GlobalData"This positive data suggests patients may have an alternative option to help them manage their cholesterol."
By meeting the primary endpoint, the trial indicated that Repatha treatment significantly decreased the need for apheresis in adult patients as measured at the end of the randomised period.
The secondary endpoints included percentage change from baseline to week four 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 found to be comparable to the placebo group.
Repatha is currently approved in more than 40 countries, including the US, Japan, Canada, and in all 28 European Union countries.
