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Amgen's Repatha (evolocumab) Receives NMPA (CFDA) Approval for Reduction of Cardiovascular Risks in China

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Amgen's Repatha (evolocumab) Receives NMPA (CFDA) Approval for Reduction of Cardiovascular Risks in China

Tuba Khan

Amgen's Repatha (evolocumab) Receives NMPA (CFDA) Approval for Reduction of Cardiovascular Risks in China

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  • The expanded indication approval is based on the results of P-III FOURIER study assessing Repatha (140mg q2w- 420 mg/month) vs PBO + statin therapy in patients with cardiovascular events
  • The study resulted in a reduction in risk of heart attack by 27%- risk of stroke by 21%- the risk of coronary revascularization by 22% and an overall reduction in cardiovascular events with safe and efficate results
  • Repatha (evolocumab) is a mAb that inhibits proprotein convertase subtilisin/kexin type 9 (PCSK9) and received NMPA approval on 31 Jul- 2018 for homozygous familial hypercholesterolemia (HoFH) in adults
Click Here  read full press release/ article | Ref: Press Reader | Image: Pic Sunday  

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