Evolocumab met the main goal of a late-stage trial titled RUTHERFORD-2 by lowering “bad” LDL cholesterol levels when tested against a placebo on 329 patients. Amgen, the world’s biggest biotechnology company, is testing evolocumab widely on a variety of subpopulations. The RUTHERFORD-2 study included patients with familial hypercholesterolemia, an inherited condition that causes high levels of “bad” LDL cholesterol starting at birth. Specifically, patients in the study had heterozygous familial hypercholesterolemia, which is one of the most common genetic disorders affecting about one out of every 300 to 500 people worldwide, according to Amgen. The company on Tuesday reported positive results from a fourth late-stage study of evolocumab, for which it plans to begin seeking approvals this year. The drug is intended for people who cannot tolerate widely used statins, or who are unable to get their LDL levels low enough despite using high potency statins, such as AstraZeneca’s Crestor. Amgen’s shares closed at $120.89 on the Nasdaq on Thursday.
Amgen's cholesterol fighter succeeds in fifth late-stage study.