Phase 3 Pivotal Data On Amgen's Novel Investigational Cholesterol-Lowering Medicine To Be Featured At The American College of Cardiology's 63rd Annual Scientific Session
"We are eager to share the detailed findings from our Phase 3 cholesterol-lowering studies of evolocumab at ACC," said
Among the abstracts are five oral presentations from the large and comprehensive evolocumab clinical trial program,
Data presented on evolocumab will include:
- Efficacy and Safety of Evolocumab (AMG 145) Monotherapy Compared With Ezetimibe and Placebo in Hypercholesterolemic Subjects: A Phase 3 Randomized Clinical Trial
Featured Clinical Research, Oral Presentation, Saturday, March 29, 2 – 2:18 p.m. EDT(Room 147 B)
- Long-term Tolerability and Efficacy of Evolocumab (AMG 145) in Hyperlipidemic Subjects: A 52-week Phase 3 Double-blind, Randomized, Placebo-controlled Study
Featured Clinical Research, Oral Presentation, Saturday, March 29, 2:18 – 2:36 p.m. EDT(Room 147 B)
- The Addition of Evolocumab (AMG 145) Allows the Majority of Heterozygous Familial Hypercholesterolemic Patients to Achieve Low-density Lipoprotein Cholesterol Goals - Results from the Phase 3 Randomized, Double-blind, Placebo-controlled Study
Featured Clinical Research, Oral Presentation, Saturday, March 29, 2:36 – 2:54 p.m. EDT(Room 147 B)
Late-Breaking Clinical Trials
- The Low-density Lipoprotein Cholesterol Assessment With PCSK9 Monoclonal Antibody Inhibition Combined With Statin Therapy - 2 Trial: A Phase 3, Double-blind, Randomized, Placebo and Ezetimibe Controlled, Multicenter Study to Evaluate Safety, Tolerability and Efficacy of Evolocumab (AMG 145) in Combination With Statin Therapy in Subjects With Primary Hypercholesterolemia and Mixed Dyslipidemia
Abstract 402-10, Late-Breaking Clinical Trials, Oral Presentation,
Sunday, March 30, 8:15 – 8:25 a.m. EDT(Hall D, Main Tent)
- A Phase 3 Double-blind, Randomized Study to Assess the Safety and Efficacy of Evolocumab (AMG 145) in Hypercholesterolemic Subjects Unable to Tolerate an Effective Dose of Statin
Abstract 402-16, Late-Breaking Clinical Trials, Oral Presentation,
Sunday, March 30, 9 – 9:10 a.m. EDT(Hall D, Main Tent)
Additional Poster Presentation
- Effects of Evolocumab on Lipoprotein Particles and Subclasses in Hypercholesterolemic and Heterozygous Familial Hypercholesterolemia Subjects on Statin Therapy
Abstract 1183-134, Poster Presentation,
Sunday, March 30, 9:45 – 10:30 a.m. EDT(Hall C)
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
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.2 Evolocumab, being developed by
The Phase 3 program includes 14 trials to evaluate evolocumab 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; as well as the administration of evolocumab (THOMAS-1 and THOMAS-2).
Five studies in the evolocumab 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 evolocumab in combination with statin therapy compared to placebo and statin therapy reduces recurrent cardiovascular events in approximately 22,500 patients with cardiovascular disease; DESCARTES (Durable Effect of PCSK9 Antibody CompARed wiTh PlacEbo Study) in patients with hyperlipidemia at risk for cardiovascular disease; 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 evolocumab 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 evolocumab on LDL-C in patients with severe familial hypercholesterolemia.
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1. Amgen Data on File, Investigator Brochure.
2. Abifadel M, et al. Mutations in PCSK9 cause autosomal dominant hypercholesterolemia.
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