CLDF Title
Home | Contact Us | Bookmark
About CLDF Centers of Educational Expertise  
Live CME Meetings Webcasts Slide Library Abstract Library Conference Highlights
Reuters Health Information (2013-10-22): New hepatitis C drug gets positive FDA review


New hepatitis C drug gets positive FDA review

Last Updated: 2013-10-22 17:12:09 -0400 (Reuters Health)

(Reuters) - A new hepatitis C drug made by Johnson & Johnson showed an acceptable safety profile in clinical trials, reviewers for the U.S. Food and Drug Administration said on Tuesday.

The drug, simeprevir, was tested in combination with standard hepatitis C drugs, peginterferon-alpha and ribavirin, in adult patients who had failed previous interferon-based therapy or had not received medication at all.

The major safety signal identified in the review of the drug involved rash and/or photosensitivity and the FDA reviewers said they plan to include a related warning in the drug's label.

The reviewers said that the drug would be categorized as a "Pregnancy Category C" in labeling, which means that the potential benefits of the drug may warrant its use in pregnant women, even though animal trials showed the drug had some adverse effects on a fetus.

The briefing documents were released prior to Thursday's meeting of an advisory panel of independent experts to discuss the drug's safety and efficacy, vote on an approval recommendation, and the need for warnings or further trials.

Hepatitis C kills more than 15,000 Americans each year, mostly from hepatitis C-related illnesses, such as cirrhosis and liver cancer.

Slide Library
Abstract Library
Slide Library
Abstract Library
Slide Library
Abstract Library
Live CME Meetings
Slide Library
Abstract Library
Slide Library
Abstract Library
CLDF Follow Us
About CLDF
Mission Statement
Board of Trustees
Board of Advisors
CLDF Supporters
Other Resources
Liver News Library
Journal Abstracts
Hep C Link to Care
Centers of
Educational Expertise
Substance Use Disorder
  The Chronic Liver Disease Foundation is a non-profit organization with content developed specifically for healthcare professionals.
© Copyright 2012-2016 Chronic Liver Disease Foundation. All rights reserved. This site is maintained as an educational resource for US healthcare providers only.
Use of this Web site is governed by the Chronic Liver Disease Foundation terms of use and privacy statement.