Drug Discovery and Development

  • Home Drug Discovery and Development
  • Drug Discovery
  • Women in Pharma and Biotech
  • Oncology
  • Neurological Disease
  • Infectious Disease
  • Resources
    • Video features
    • Podcast
    • Voices
    • Webinars
  • Pharma 50
    • 2025 Pharma 50
    • 2024 Pharma 50
    • 2023 Pharma 50
    • 2022 Pharma 50
    • 2021 Pharma 50
  • Advertise
  • SUBSCRIBE

Amgen’s Repatha Meets Primary Endpoint in Phase 3 Study

By Amgen | March 13, 2017

Repatha (evolocumab) demonstrates reduced need for apheresis in patients with high LDL cholesterol in Phase 3 study.

Amgen today announced positive top-line results from a Phase 3 study evaluating Repatha (evolocumab) in patients who were receiving apheresis to reduce low-density lipoprotein cholesterol (LDL-C).

The study met its primary endpoint, demonstrating that treatment with Repatha significantly reduced the need for LDL-C apheresis in adult patients, as measured at the end of the randomized period. The study also met its secondary endpoints of percent change from baseline to week 4 in LDL-C, non-high-density lipoprotein cholesterol (non-HDL-C) and total cholesterol:HDL-C ratio. 

“Patients who require apheresis to help control their LDL-C have limited treatment options and face the daunting challenge of frequent, invasive and costly procedures,” said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. “These positive data suggest patients may have an alternative option to help them manage their cholesterol.”

The overall incidence of treatment-emergent adverse events was comparable among both groups. No new safety concerns were identified in this study. 

Detailed results will be submitted to a future medical conference and for publication.

Apheresis is an invasive procedure similar to dialysis, in which a special machine removes LDL-C from a patient’s plasma.1  The process can be time consuming and burdensome for patients, as the weekly or bi-weekly treatments can take between one to three hours. Many patients also travel long distances for treatment as there are only approximately 60 apheresis centers in the United States.2

In the U.S., there are approximately 11 million people with atherosclerotic cardiovascular disease (ASCVD) and/or familial hypercholesterolemia (FH) who have uncontrolled levels of LDL-C over 70 mg/dL, despite treatment with statins or other cholesterol-lowering therapies.3,4  

Study Design

Thirty-nine adult patients with LDL-C levels between ≥100 mg/dL and ≤190 mg/dL despite regular weekly or biweekly apheresis plus statin therapy (if tolerated) were randomized to receive either Repatha subcutaneously every two weeks or continue LDL-C apheresis (every one or two weeks, according to their schedule before entering the study) for the first six weeks. Beginning at week six, all patients were given Repatha.

The primary endpoint evaluated the efficacy of subcutaneous Repatha, compared to regularly scheduled LDL-C apheresis, on reducing the need for continued apheresis at the end of the randomized period. Secondary endpoints measured the effects of Repatha compared with apheresis at week four on levels of LDL-C, non-HDL-C and total cholesterol:HDL-C ratio.

(Source: PR Newswire)


Filed Under: Drug Discovery

 

Related Articles Read More >

Sanders, King target DTC pharma ads but the industry worries more about threats to its $2B R&D model
Zoliflodacin wins FDA nod for treatment of gonorrhea
FDA approved ENFLONSIA for the prevention of RSV in Infants
First clinical study results of Dupixent for atopic dermatitis in patients with darker skin tones 
“ddd
EXPAND YOUR KNOWLEDGE AND STAY CONNECTED
Get the latest news and trends happening now in the drug discovery and development industry.

MEDTECH 100 INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.
Drug Discovery and Development
  • MassDevice
  • DeviceTalks
  • Medtech100 Index
  • Medical Design Sourcing
  • Medical Design & Outsourcing
  • Medical Tubing + Extrusion
  • Subscribe to our E-Newsletter
  • Contact Us
  • About Us
  • R&D World
  • Drug Delivery Business News
  • Pharmaceutical Processing World

Copyright © 2025 WTWH Media LLC. All Rights Reserved. The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media
Privacy Policy | Advertising | About Us

Search Drug Discovery & Development

  • Home Drug Discovery and Development
  • Drug Discovery
  • Women in Pharma and Biotech
  • Oncology
  • Neurological Disease
  • Infectious Disease
  • Resources
    • Video features
    • Podcast
    • Voices
    • Webinars
  • Pharma 50
    • 2025 Pharma 50
    • 2024 Pharma 50
    • 2023 Pharma 50
    • 2022 Pharma 50
    • 2021 Pharma 50
  • Advertise
  • SUBSCRIBE