Studies show Repatha (evolocumab) cuts LDL-C levels in familial hypercholesterolemia - Amgen

Amgen has announced data presented at the European Society of Cardiology (ESC) Congress 2016 showing Repatha (evolocumab) consistently reduced low-density lipoprotein cholesterol (LDL-C) in patients with familial hypercholesterolemia (FH). Researchers looking at the "Long-term safety, tolerability and efficacy of evolocumab in patients with heterozygous familial hypercholesterolaemia," found that treatment with Repatha for 48 weeks resulted in persistent and marked LDL-C reductions in these patients.

The analysis showed that Repatha plus standard of care (SoC) reduced LDL-C levels from baseline by 53.6 percent at 48 weeks (n=279), compared to a 2.1 percent increase for SoC alone (n=139). The pooled analysis included 440 patients with heterozygous familial hypercholesterolemia (HeFH) who completed Amgen's RUTHERFORD-1 (Phase II) or RUTHERFORD-2 (Phase III) trials and entered open-label extension trials (OSLER-1 or OSLER-2). Patients were randomized in the extension trials to receive SoC alone or Repatha plus SoC. Repatha was well tolerated in the extension studies with no new safety signals. The rates of overall adverse events were similar for the two groups, occurring in 80 percent of patients receiving Repatha and 67 percent of patients receiving SoC.