FDA Expands Repatha® (Evolocumab) Use for At-Risk Adults

FDA Expands Repatha® (Evolocumab) Use for At-Risk Adults
Published on
1 min read

Amgen announced that the U.S. Food and Drug Administration (FDA) has expanded the indication for Repatha® (evolocumab). The therapy can now be prescribed to adults at increased risk of major adverse cardiovascular events (MACE) due to uncontrolled low-density lipoprotein cholesterol (LDL-C), even if they do not have a prior cardiovascular disease diagnosis.

“Too many adults remain unable to meet their LDL-C goals, despite cholesterol being one of the most modifiable risk factors for heart attack or stroke,” said Murdo Gordon, executive vice president of Global Commercial Operations at Amgen. “This update underscores the urgent need for more treatment options. Repatha offers an effective solution, especially for patients whose cholesterol is not controlled with statins or who cannot tolerate them.”

The FDA also broadened Repatha’s use to include:

  • Monotherapy for patients with homozygous familial hypercholesterolemia (HoFH), a rare genetic disorder.

  • Continued emphasis on its use alongside diet and exercise for cholesterol management.

Repatha, first approved in 2015, has been used by over 5 million patients worldwide.

Related Stories

No stories found.
Voice Of HealthCare
vohnetwork.com