Repatha is a fully human monoclonal antibody that inhibits proprotein convertase subtilisin/kexin type 9 (PCSK9), a protein that reduces the liver's ability to remove low-density lipoprotein cholesterol (LDL-C), or "bad" cholesterol, from the blood.1 Corlanor is an oral drug that acts on the body's cardiac pacemaker to slow the heart rate without negative effects on myocardial contractility or ventricular repolarization.2
"As we head into a milestone-filled year for our cardiovascular pipeline, we are eager to share safety analyses and data exploring the effect of Repatha on LDL cholesterol and cardiovascular events and new analyses on the efficacy of Corlanor in patients with chronic heart failure at ACC's Scientific Session this year," said
Among the abstracts is a Late-Breaking Clinical Trial presentation of LDL-C lowering and major adverse cardiovascular event data after one year of treatment from the OSLER-1 and -2 (Open Label Study of Long TERm Evaluation Against LDL-C) studies in the Repatha program, and an oral presentation of long-term data from the OSLER-1 trial evaluating the safety and efficacy of Repatha after two years of treatment. Repatha data presentations also include a pooled safety analysis in over 6,000 patients from Phase 2 and 3 short- and long-term clinical trials.
The Phase 3 results from the YUKAWA-2 (StudY of LDL-Cholesterol Reduction Using a Monoclonal PCSK9 Antibody in Japanese Patients With Advanced Cardiovascular Risk) study evaluating Repatha in combination with statin therapy in Japanese patients with high cardiovascular risk and high cholesterol will also be presented.
Additionally, two analyses from the Phase 3 SHIFT (Systolic Heart failure treatment with the If Inhibitor Ivabradine Trial) study evaluating Corlanor will be presented. These data include an oral presentation on the efficacy profile of Corlanor in patients with chronic heart failure and angina, and a poster on whether the addition of Corlanor to optimized background therapy affects beta blocker usage.
Data to be presented at ACC.15 include:
Late-Breaking and Oral Presentations
Live audio of the investor meeting will be simultaneously broadcast over the Internet and will be available to members of the news media, investors and the general public.
The webcast, as with other selected presentations regarding developments in
About RepathaTM (evolocumab)
RepathaTM (evolocumab) is a fully human monoclonal antibody that inhibits proprotein convertase subtilisin/kexin type 9 (PCSK9).1 PCSK9 is a protein that targets LDL receptors for degradation and thereby reduces the liver's ability to remove LDL-C, or "bad" cholesterol, from the blood.3 Repatha, being developed by
The Phase 3 program includes 16 trials to evaluate Repatha administered every two weeks and monthly in multiple patient populations, including in combination with statins in patients with hyperlipidemia (LAPLACE-2 and YUKAWA-2); in patients with hyperlipidemia who cannot tolerate statins (GAUSS-2 and GAUSS-3); as a stand-alone treatment in patients with hyperlipidemia (MENDEL-2); in patients whose elevated cholesterol is caused by genetic disorders called heterozygous (RUTHERFORD-2 and TAUSSIG) and homozygous (TESLA and TAUSSIG) familial hypercholesterolemia; the effects of Repatha on lipoprotein metabolism (FLOREY); and the administration of Repatha in statin-treated hyperlipidemic patients (THOMAS-1 and THOMAS-2).
Five ongoing studies in the Repatha Phase 3 program will provide long-term safety and efficacy data. These include FOURIER (Further Cardiovascular OUtcomes Research with PCSK9 Inhibition in Subjects with Elevated Risk), which will assess whether treatment with Repatha in combination with statin therapy compared to placebo and statin therapy reduces recurrent cardiovascular events in approximately 27,500 patients with cardiovascular disease; EBBINGHAUS (Evaluating PCSK9 Binding AntiBody Influence oN CoGnitive HeAlth in High CardiovascUlar Risk Subjects), which will evaluate the effect of Repatha on cognitive function in a subset of patients enrolled in FOURIER; OSLER-2 (Open Label Study of Long TERm Evaluation Against LDL-C Trial-2) in patients with high cholesterol who completed any of the Phase 3 studies; GLAGOV (GLobal Assessment of Plaque ReGression with a PCSK9 AntibOdy as Measured by IntraVascular Ultrasound), which will determine the effect of Repatha on coronary atherosclerosis in approximately 950 patients undergoing cardiac catheterization; and TAUSSIG (Trial Assessing Long Term USe of PCSK9 Inhibition in Subjects with Genetic LDL Disorders), which will assess the long-term safety and efficacy of Repatha on LDL-C in patients with severe familial hypercholesterolemia including patients with homozygous familial hypercholesterolemia. The DESCARTES (Durable Effect of PCSK9 Antibody CompARed wiTh PlacEbo Study) study, a long-term safety and efficacy trial in patients with hyperlipidemia at risk for cardiovascular disease, has been completed.
About Corlanor® (ivabradine)
Corlanor® (ivabradine) is an investigational oral drug that inhibits the If current ("funny" current) in the sinoatrial node, the body's cardiac pacemaker.2 Corlanor works to slow the heart rate without negative effects on myocardial contractility or ventricular repolarization.2 Developed by Les Laboratoires Servier, Corlanor was approved by the
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