FDA Expands Evolocumab to Treat Adults at Increased Risk for Major Adverse Cardiovascular Events

FDA Expands Use of Repatha

tim.hodson Tue, 08/26/2025 - 10:25 Aug. 25, 2025 — Amgen has announced that the U.S. Food and Drug Administration (FDA) has broadened the approved use of Repatha (evolocumab) to include adults at increased risk for major adverse cardiovascular events (MACE) due to uncontrolled low-density lipoprotein cholesterol (LDL-C), commonly known as "bad cholesterol." The update removes a prior requirement for a patient to have been diagnosed with cardiova…

FDA Expands Approval of Evolocumab to Include Patients at Increased Risk of MACE

The FDA removes the prior requirement for a patient who is already diagnosed with a cardiovascular disease.

FDA Expands Evolocumab to Treat Adults at Increased Risk for Major Adverse Cardiovascular Events

Evolocumab is now indicated for adults at increased risk for major adverse cardiovascular events (MACE).