Amgen Announces New Data from Two OLE Studies of PCSK9 Inhibitor Repatha in ASCVD

Compilenewborn

Recently, Amgen announced the top-line results of two open-label extension (OLE) studies of the PCSK9 inhibitor lipid-lowering drug Repatha (Repatha, generic name: evolocumab) Phase 3 FOURIER cardiovascular outcomes trial

The FOURIER-OLE study consisted of Study 20130295 (NCT02867813), which enrolled 5035 patients in Eastern Europe and the United States, and Study 20160250 (NCT03080935), which enrolled 1600 patients in Western Europe

Additionally, during the OLE study, medically significant and sustained reductions in low-density lipoprotein cholesterol (LDL-C) levels were observed, with more than 85% of patients achieving LDL-C levels <40 mg/dL

Other study measures included levels of non-HDL cholesterol, apolipoprotein B, total cholesterol, lipoprotein(a), triglycerides, high density lipoprotein cholesterol, very low density lipoprotein cholesterol, and apolipoprotein A-1.

Detailed findings will be shared with regulatory agencies and will be presented at a medical congress later this year

Repatha is a monoclonal antibody that binds to the proprotein convertase subtilisin kexin type 9 (PCSK9), inhibits the binding of circulating PCSK9 to the low-density lipoprotein (LDL) receptor (LDLR), and prevents PCSK9-mediated LDLR is degraded so that LDLR can be recycled back to the surface of hepatocytes

The results of the two OLE studies published this time confirmed the good safety profile of long-term use of Repahta to lower LDL-C

Reference source: AMGEN ANNOUNCES RESULTS FROM TWO OPEN LABEL EXTENSION STUDIES OF REPATHA® (EVOLOCUMAB)