FDA Approves Second PCSK9 Inhibitor for High Cholesterol
The Food and Drug Administration (FDA) has approved Repatha (evolocumab; Amgen) for use in addition to diet and maximally-tolerated statin therapy in adults with heterozygous familial hypercholesterolemia (HeFH), homozygous familial hypercholesterolemia (HoFH), or clinical atherosclerotic cardiovascular disease, such as heart attacks or strokes, who require additional lowering of low-density lipoprotein cholesterol (LDL-C).
Evolocumab binds to PCSK9 and inhibits circulating PCSK9 from binding to the LDL receptor (LDLR), preventing PCSK9-mediated LDLR degradation and permitting LDLR to recycle back to the liver cell surface. Evolocumab increases the number of LDLRs available to clear LDL from the blood, thereby lowering LDL-C levels.
The safety and efficacy of Repatha were studied in one 52-week placebo-controlled trial and eight 12-week placebo-controlled trials in patients with primary hyperlipidemia; two specifically enrolled patients with HeFH and one enrolled patients with HoFH. In one of the trials (n=329), patients with HeFH were randomized to Repatha or placebo for 12 weeks. An average LDL-C reduction of 60% was seen in the Repatha group vs. placebo.
Repatha is the second drug in the new proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor drug class that has been approved; in July 2015, Praluent (alirocumab; Sanofi Aventis and Regeneron) was approved as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia (HeFH) or clinical atherosclerotic cardiovascular disease, who require additional lowering of LDL-C.
Repatha injection will be available as 140mg/mL strength single-use prefilled syringes, and as 140mg/mL single-use prefilled SureClick autoinjectors in 1-, 2- and 3-count packs starting next week. The Company also plans to make a single injection monthly dosing available next year.
For more information call (800) 772-6436 or visit Repatha.com.