Amgen's Repatha sustains reduction in bad cholesterol as per long term data from 2 studies
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Amgen (NASDAQ:AMGN) said data from two studies showed that its drug Repatha sustained reduction in 'bad' cholesterol.
Data was from two open label extension (OLE) studies to the phase 3 trial, dubbed FOURIER.
The FOURIER-OLE studies were composed of trial 20130295 (NCT02867813) with 5,035 patients enrolled in Eastern Europe and the U.S. and study 20160250 (NCT03080935) with 1,600 patients enrolled in Western Europe.
The Thousand Oaks, Calif.-based company said both studies showed that Repatha (evolocumab) given at 140 mg every two weeks or 420 mg monthly was safe and well-tolerated.
In the OLE studies, patients received Repatha for ~5 years, with some patients receiving Repatha for up to 8 1/2 years in total across the FOURIER and OLE studies.
No new long-term safety findings were seen, said the company in an April 27 press release.
Amgen said that medically significant and sustained reduction in low-density lipoprotein cholesterol (LDL-C) â also known as 'bad' cholesterol â levels were seen, with more than 85% of patients achieving an LDL-C level of <40 mg/dL during the OLE period.
"The combined results from these studies reinforce the well-established safety profile of Repatha with long-term use in lowering LDL-C," said David Reese, executive vice president of Research and Development at Amgen.
Repatha is approved for certain uses, including for adults with cardiovascular disease to reduce the risk of heart attack.