Amgen (AMGN) said Monday that the US Food and Drug Administration has broadened the approved use of Repatha to include adults at increased risk for major adverse cardiovascular events due to uncontrolled low-density lipoprotein cholesterol, or "bad cholesterol."
The FDA's move eliminates the previous requirement that a patient be diagnosed with cardiovascular disease, the company said.
In addition, the regulator also broadened the use of Repatha along to include patients with a rare form of high cholesterol called homozygous familial hypercholesterolemia; and emphasized that Repatha should be used together with diet and exercise to manage high cholesterol, Amgen said.
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