Amgen’s Repatha will now be used as the first PCSK9 inhibitor in China for adults with established atherosclerotic cardiovascular disease (ASCVD) to reduce the risk of myocardial infarction, stroke and coronary revascularization.
The US-based drugmaker said Friday that the National Medical Products Administration (NMPA) has approved a new indication for its evolocumab as the first such PCSK9 inhibitor in China.
Murdo Gordon, Amgen’s executive vice president of Global Commercial Operations said that this brings Amgen opporutnity to bring more medicines to Chine. “The new expanded label in China is an important milestone providing high-risk patients, who are unable to control their LDL-C with statin therapy alone, with a new treatment option to help prevent life-changing heart attacks and strokes”
On July 31, 2018, Repatha was approved by the NMPA as the first PCSK9 inhibitor in China for the treatment of adults and adolescents over 12 years old with homozygous familial hypercholesterolemia (HoFH).