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 News
    • Trending
    • Commercial Operations
    • GMPs
    • FDA Enforcement Actions
    • Inspections and Audits
    • Postmarket Safety
    • Quality
    • Regulatory Affairs
    • Research and Development
    • Submissions and Approvals
    • FDAnews Drug Weekly
    • FDAnews
  • Device News
    • Trending
    • Commercial Operations
    • FDA Enforcement Actions
    • Inspections and Audits
    • Postmarket Safety
    • Quality
    • Regulatory Affairs
    • Research and Development
    • Submissions and Approvals
    • FDAnews Device Weekly
    • FDAnews
  • Books
    • FDAnews Books Library
    • Drug Books
    • Device Books
  • Training/Events
    • Webinar Training Pass
    • Events
    • Webinar Recordings
  • Resources
    • Form 483s Database
    • FDA Approved Drugs
  • CenterWatch
  • About Us
    • The Company
    • FDAnews Editorial Board
    • Contact Us
  • Advertising
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » First Treatment for Liver Scarring Gets FDA Approval

First Treatment for Liver Scarring Gets FDA Approval

March 19, 2024

The FDA’s approval on Thursday of Madrigal Pharmaceutical’s Rezdiffra (resmetirom) is the first for the treatment of adults with noncirrhotic non-alcoholic steatohepatitis (NASH) with moderate to advanced liver scarring (fibrosis).

Rezdiffra is a partial activator of a thyroid hormone receptor; activation of this receptor by Rezdiffra in the liver reduces liver fat accumulation.

NASH (formerly MASH — metabolic dysfunction-associated steatohepatitis) is a result of the progression of nonalcoholic fatty liver disease where liver inflammation can lead to liver scarring and liver dysfunction. By at least one estimate, approximately 6-8 million people in the U.S. have NASH with moderate to advanced liver scarring. Rezdiffra is expected to be available to patients in the U.S. in April.

Read the FDA announcement here.

To read the whole story, click here to subscribe.

Related Topics

Drugs Submissions and Approvals

    Upcoming Events

    • 21Mar

      FDA as a Development Partner: A New Approach to Product Review Meetings

    • 28Mar

      The Inflation Reduction Act (IRA): How Will It Impact Drug Development?

    • 04Apr

      Managing Data and Documentation for FDA Inspections and Remote Assessments

    • 11Apr

      Integrating Regulatory Intelligence into Supplier Management

    • 14Apr

      MAGI 2024: The Clinical Research Conference

    • 25Apr

      A Masterclass on Effective 483 Responses

    Featured Products

    • FDA, FTC and DOJ Enforcement of Medical Device Regulations

      FDA, FTC and DOJ Enforcement of Medical Device Regulations

    • Using Real-World Evidence in Drug and Device Submissions

      Using Real-World Evidence in Drug and Device Submissions

    Featured Stories

    • Drug Shortages, Hatch-Waxman Amendments Lead FDA’s 2025 Legislative Agenda

    • Two Medical Device Draft Guidances Detail Thermal Effects, Q-Submission Process

    • First Treatment for Liver Scarring Gets FDA Approval

    • Final EtO Amendments Aimed at Reducing Emissions by 90 Percent

    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 © 2024. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing