Repatha OKed in China for CD risk reduction

China’s National Medical Products Administration (NMPA) has approved a new indication for Repatha (evolocumab) as the first PCSK9 inhibitor in China.

The drug’s developer, US biotech major Amgen (Nasdaq: AMGN), says the new indication is for adults with established atherosclerotic cardiovascular disease (ASCVD) to reduce the risk of myocardial infarction, stroke and coronary revascularization.

Low-density lipoprotein cholesterol (LDL-C) is one of the key modifiable risk factors for the development of cardiovascular disease. Decades of studies have demonstrated that reductions in cardiovascular risk are proportional to absolute reductions in LDL-C levels, making LDL-C the primary treatment target for the reduction of cardiovascular events. Yet, even among patients with cardiovascular disease currently taking a lipid-lowering therapy, many still do not meet recommended LDL-C goals and remain at risk for cardiovascular events, the company noted.