CLDF Title
Home | Contact Us | Bookmark
About CLDF Centers of Educational Expertise  
Live CME Meetings Telewebs Webcasts Slide Library Abstract Library Conference Highlights
Reuters Health Information (2011-01-20): Vertex Pharma's hepatitis C drug gets priority review


Vertex Pharma's hepatitis C drug gets priority review

Last Updated: 2011-01-20 10:57:27 -0400 (Reuters Health)

by Vidya L Nathan

BANGALORE (Reuters) - Vertex Pharmaceuticals Inc said its experimental treatment for hepatitis C got priority review status from health regulators in the United States and Canada.

Cambridge, Massachusetts-based Vertex, which had asked the U.S. Food and Drug Administration for a priority review of data from telaprevir in November, said the agency set an action date for May 23 to decide on the approval.

Priority review status from the FDA reduces the review period by 4 month, the company said. The same status from Canadian health regulator Health Canada cuts short the review period to 6 to 9 months, compared to a review period of 18 months or more.

Vertex is developing telaprevir in collaboration with Tibotec Pharmaceuticals, a unit of Johnson & Johnson, and Mitsubishi Tanabe Pharma.

Vertex holds rights to market the drug in North America while Tibotec has rights to market it in Europe, South America, Australia, the Middle East and certain other countries. Mitsubishi Tanabe has rights in Japan and certain Far East countries.

Slide Library
Abstract Library
Slide Library
Abstract Library
Slide Library
Abstract Library
Live CME Meetings
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
Regional Map
  The Chronic Liver Disease Foundation is a non-profit organization with content developed specifically for healthcare professionals.
© Copyright 2012-2015 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.