China’s NMPA approves Amgen’s Repatha to reduce cardiovascular event risk
pharmafile | January 25, 2019 | News story | Medical Communications, Sales and Marketing | Amgen, China, Repatha, cardiovascular disease, pharma, stroke
Amgen has announced that its proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor Repatha (evolocumab) has secured approval by China’s drug regulator, the National Medical Products Administration (NMPA), to reduce the risk of myocardial infarction, stroke and coronary revascularisation in adult patients with established atherosclerotic cardiovascular disease (ASCVD).
The decision makes the drug the first PCSK9 inhibitor available in the nation for this indication. It was based on data derived from 27,564 patients, which demonstrated that the drug, in combination with statin therapy, reduced the risk of heart attack by 27%, the risk of stroke by 21%, and the risk of coronary revascularisation by 22% throughout the trial’s median 26 months.
The drug was previously approved by the NMPA in the treatment of patients over the age of 12 with homozygous familial hypercholesterolemia (HoFH) in July last year.
“Cardiovascular disease has become one of the greatest health challenges facing Chinese citizens today,” said Professor Changsheng Ma, of Beijing Anzhen Hospital, Capital Medical University. “High levels of LDL-C have been proven to increase the risk of developing ASCVD. If such levels of LDL-C fail to be managed, patients will become increasingly susceptible to strokes and heart attacks. However, existing therapies have limitations and many patients fail to effectively control their LDL-C levels to prevent recurrent cardiovascular events. The approval of this new indication offers hope for patients who continue to struggle with achieving lower LDL-C levels, providing another treatment against cardiovascular events.”
Murdo Gordon, Executive Vice President of Global Commercial Operations at Amgen, also remarked: “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,” “This is also an important step for Amgen as we continue to bring innovative medicines to China and build our presence.”
Matt Fellows
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