FDA Approves Second PCSK9 Inhibitor

The U.S. Food and Drug Administration (FDA) on August 27 approved Amgen’s Repatha (evolocumab) as a treatment to lower low-density lipoprotein cholesterol in patients with heterozygous familial hypercholesterolemia, homozygous familial hypercholesterolemia or clinical atherosclerotic cardiovascular disease. This is the second proprotein convertase subtilisin kexin type 9 (PCSK9) inhibitor approved this year, following the approval of the Praluent (alirocumab) injection in July.

According to the FDA, the new drug should be used in addition to diet and maximally-tolerated statin therapy. Side effects of this PCSK9 inhibitor include nasopharyngitis, upper respiratory tract injection, flu, back pain and bruising at the site of injection.

Read the FDA announcement.


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