Amgen present data on REPATHA

Amgen announced that it will present 14 abstracts at the American Heart Association (AHA) Scientific Sessions 2015, from Nov. 7–11 in Orlando, Fla. New data analyses evaluating Repatha™ (evolocumab), an injectable proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor approved for certain patients with high low-density lipoprotein cholesterol (LDL-C), or "bad" cholesterol, and Corlanor^® (ivabradine), an oral medicine for certain people who have chronic (long-lasting) heart failure caused by the lower-left part of their heart not contracting well, will be presented at the meeting. 

Repatha, approved by the U.S. Food and Drug Administration (FDA) on Aug. 27, is indicated 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 (ASCVD), who require additional lowering of LDL-C; and as an adjunct to diet and other LDL-lowering therapies for the treatment of patients with homozygous familial hypercholesterolemia (HoFH), who require additional lowering of LDL-C. The effect of Repatha on cardiovascular morbidity and mortality has not been determined.  

Corlanor, approved by the FDA on April 15, is indicated to reduce the risk of hospitalization for worsening heart failure in patients with stable, symptomatic chronic heart failure with left ventricular ejection fraction <35 percent, who are in sinus rhythm with resting heart rate >70 beats per minute and either are on maximally tolerated doses of beta blockers or have a contraindication to beta blocker use.

In addition to Repatha and Corlanor clinical trial analyses, data from Amgen's Center for Observational Research will be presented, including a poster and oral presentation on findings from the REGARDS (REasons for Geographic And Racial Differences in Stroke) study, and an oral presentation on the benefits of initiating beta blocker treatment in heart failure patients within seven days following hospital discharge. A global health economics study on the association between achievement of LDL-C reduction targets and cardiovascular disease risk among patients with familial hypercholesterolemia will also be presented.

Amgen Submits Application To FDA For New Delivery Option For Monthly Administration Of Repatha

Amgen announced the submission of an application to the U.S. Food and Drug Administration (FDA) seeking approval of a single-dosing option for the monthly administration of Repatha (evolocumab) Injection, allowing the 420 mg monthly dose to be administered as a single injection. Approved by the FDA on Aug. 27, 2015, Repatha is a human monoclonal antibody that inhibits proprotein convertase subtilisin/kexin type 9 (PCSK9). PCSK9 is a protein that reduces the liver's ability to remove low-density lipoprotein cholesterol (LDL-C), or "bad" cholesterol, from the blood.

Repatha is approved as an adjunct to diet and maximally tolerated statins in patients with heterozygous familial hypercholesterolemia (HeFH) or clinical atherosclerotic cardiovascular disease (ASCVD), who require additional lowering of LDL-C; and as an adjunct to diet and other LDL-lowering therapies for the treatment of patients with homozygous familial hypercholesterolemia (HoFH), who require additional lowering of LDL-C. The effect of Repatha on cardiovascular morbidity and mortality has not been determined.

Repatha (evolocumab) is a human monoclonal antibody that inhibits proprotein convertase subtilisin/kexin type 9 (PCSK9).1 Repatha binds to PCSK9 and inhibits circulating PCSK9 from binding to the low-density lipoprotein (LDL) receptor (LDLR), preventing PCSK9-mediated LDLR degradation and permitting LDLR to recycle back to the liver cell surface. By inhibiting the binding of PCSK9 to LDLR, Repatha increases the number of LDLRs available to clear LDL from the blood, thereby lowering LDL-C levels.