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.
  • SKIP TO CONTENT
  • SKIP NAVIGATION
  • Drug Products
    • Books
    • FDAnews Books Library
    • Events
    • Form 483s Database
    • Subscription Newsletters
    • Free Newsletters
    • Webinar Training Pass
    • eCFR and Guidances
  • Device Products
    • Books
    • FDAnews Books Library
    • Events
    • Form 483s Database
    • Subscription Newsletters
    • Free Newsletters
    • Webinar Training Pass
    • eCFR and Guidances
  • Clinical Products
  • Advertising
  • White Papers
  • Contact Us
  • About Us
  • COVID-19
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » Novartis’ Cholesterol Drug Endorsed by EMA Advisory Group

Novartis’ Cholesterol Drug Endorsed by EMA Advisory Group

October 19, 2020

The EMA’s Committee for Medicinal Products for Human Use (CHMP) has recommended that the agency issue a marketing authorization for Novartis’ Leqvio (inclisiran) for adult patients with high cholesterol levels who are at risk for cardiovascular disease.

The company is seeking approval for the drug’s use as an adjunct to diet in combination with a statin, or a statin with other lipid‑lowering therapies, for patients who don’t respond to a maximum tolerated dose of a statin.

The marketing authorization would also include the drug’s use alone or in combination with other lipid-lowering therapies in patients who are statin‑intolerant.

Leqvio will be available as a 284-mg solution for injection. The treatment only requires two injections per year and could help 80 percent of high-risk patients in Europe, the company said.

The FDA is also evaluating the drug as an adjunct treatment for high blood cholesterol.

View today's stories

Pharmaceuticals Submissions and Approvals

Upcoming Events

  • 10Mar

    FDA Drug GMP Facility Inspections During the Pandemic

  • 16Mar

    Pharmaceutical Naming Regulation: Understanding the Latest Developments

  • 18Mar

    Pharmaceutical Postmarket Surveillance: Latest Developments in the Era of COVID-19

  • 23Mar

    Data Integrity for GCP Professionals: Core Requirements, Expectations and Challenges

  • 30Mar

    Data Integrity for GMP/Postmarket Professionals: Core Requirements, Expectations and Challenges

  • 06Apr

    Medical Device Cybersecurity: Understand the Latest Developments

Featured Products

  • Biological Risk Evaluation and Management for Medical Devices

  • GMP Inspection Preparation Checklist: A Tool for Internal Auditing

Featured Stories

  • UKflag.jpg

    UK Study Says Single Shot of Pfizer/BioNTech Vaccine Significantly Lessened Asymptomatic Infections

  • emergency use authorization approved

    Eurofins Receives FDA Emergency Authorization for Over-the-Counter COVID-19 Test

  • FDA clears text

    Vetex Medical’s Thrombectomy Catheter Cleared by FDA

  • 100Bills_flatmoney.gif

    Merck Purchases Rights to Debiopharm’s Xevinapant for More Than $1 Billion

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 My Personal Information
Footer Logo

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

Phone 703.538.7600 – Fax 703.538.7676 – Toll free 888.838.5578

Copyright © 2021. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing