We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
Accept
  • SKIP TO CONTENT
  • SKIP NAVIGATION
  • Drug & Device Products
    • FDAnews Books Library
    • Events
    • Form 483s Database
    • Publications
    • Webinar Training Pass
    • eCFR and Guidances
    • Books
  • Clinical Products
  • Advertising
  • White Papers
  • Contact Us
  • About Us
  • COVID-19
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » FDA Grants Priority Review to Amarin’s Cardiovascular Drug

FDA Grants Priority Review to Amarin’s Cardiovascular Drug

FDA_Logo_Black_2016.gif
June 5, 2019

The FDA granted priority review to Amarin’s Vascepa, a drug design to cut the risk of cardiovascular disease.

If approved, Vascepa (icosapent ethyl) would be the first drug of its kind on the U.S. market. It targets the residual heart disease risk for patients who manage their cholesterol with statins but still have continuing problems with high triglycerides.

The accelerated approval comes after Amarin handed up data from its REDUCE-IT trial, which were also published in the New England Journal of Medicine last year. The study of more than 8,100 patients found that participants  in the Vascepa group saw a 26 percent reduction in the risk of a stroke, heart attack or unstable angina.

Amarin expects to hear the FDA’s decision by Sept. 28.

View today's stories

Pharmaceuticals Regulatory Affairs

Upcoming Events

  • 08Feb

    Process and Design Validation for Devicemakers: A Deep Dive into Best Practices, Recent Trends and Regulatory Definitions

  • 09Feb

    The Inextricable Link Between Data Integrity and Quality Culture

  • 15Feb

    Advanced Compliance Writing CAPA: Mastering Failure Investigation and Root Cause Analysis

  • 16Feb

    Fundamentals of FDA Inspection Management: Reduce Anxiety, Increase Inspection Success

  • 22Feb

    Best Practices for Developing and Maintaining a GxP Training Matrix

  • 07Mar

    FDA’s Remote Assessments v. Remote Interactive Evaluations: Do You Really Know the Difference?

Featured Products

  • FDA’s New Quality System Regulation: Transitioning from QSR to ISO 13485

    FDA’s New Quality System Regulation: Transitioning from QSR to ISO 13485

  • Selecting and Implementing Electronic Document Management Systems in the EU

    Selecting and Implementing Electronic Document Management Systems in the EU

Featured Stories

  • FDA Updates Smiths Medical CADD System Recall to Class I

  • Eisai’s New Alzheimer’s Drug Leqembi Hits the U.S. Market

  • Boston Scientific’s Single Use Ureteroscope Gets FDA Clearance

  • Gilead’s Trodelvy Gets Expanded Approval in Breast Cancer

The Revised ICH E8: A Guide to New Clinical Trial Requirements

Learn More
  • Drug Products
    • Quality
    • Regulatory Affairs
    • GMPs
    • Inspections and Audits
    • Postmarket Safety
    • Submissions and Approvals
    • Research and Development
    • Commercial Operations
  • Device Products
    • Quality
    • Regulatory Affairs
    • QSR
    • Inspections and Audits
    • Postmarket Safety
    • Submissions and Approvals
    • Research and Development
    • Commercial Operations
  • Clinical Products
    • Trial Design
    • Data Integrity
    • GCP
    • Inspections and Audits
    • Transparency
  • Privacy Policy
  • Do Not Sell or Share My Data
Footer Logo

300 N. Washington St., Suite 200, Falls Church, VA 22046, USA

Phone 703.538.7600 – Toll free 888.838.5578

Copyright © 2023. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing