Amgen announces two Phase III studies, GAUSS-2 and LAPLACE-2 of evolocumab for High Cholesterol

Amgen has announced new detailed data from two Phase III pivotal studies that showed treatment with its novel investigational cholesterol-lowering medication, evolocumab (AMG 145), resulted in a statistically significant reduction in low-density lipoprotein cholesterol (LDL-C) between 37-39 percent, compared to ezetimibe in patients with high cholesterol who cannot tolerate statins (GAUSS-2) and between 55-76 percent compared to placebo when used in combination with statin therapy in patients with high cholesterol (LAPLACE-2). Results from the two separate Phase III studies, GAUSS-2 and LAPLACE-2, were presented today as Late-Breaking Clinical Trials and complement the three Phase 3 studies presented yesterday as Featured Clinical Research at the American College of Cardiology's 63rd Annual Scientific Session (ACC.14).

Positive results from the GAUSS-2 study were simultaneously published in the Journal of the American College of Cardiology.

See-"Anti-PCSK9 Antibody Effectively Lowers Cholesterol in Patients with Statin Intolerance: The GAUSS-2 Randomized, Placebo-controlled Phase 3 Clinical Trial of Evolocumab"- Original Research Article Journal of the American College of Cardiology, In Press, Accepted Manuscript, Available online 30 March 2014 Erik Stroes, David Colquhoun, David Sullivan, Fernando Civeira, Robert S. Rosenson, Gerald F. Watts, Eric Bruckert, Leslie Cho, Ricardo Dent, Beat Knusel, Allen Xue, Rob Scott, Scott M. Wasserman, Michael Rocco, GAUSS-2 Investigators.