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CDC HIV/AIDS/Viral Hepatitis/STD/TB Prevention News Update

UNITED STATES: FDA Gives Bristol-Myers' Hepatitis Drug 'Breakthrough' Designation


Fox Business (02.24.2014)

Fox Business reported that the US Food and Drug Administration (FDA) awarded “breakthrough therapy designation” to Bristol-Myers Squibb’s investigational treatment for hepatitis C virus (HCV) infection on February 24. This rare designation expedites the development and review process of drugs for serious or life-threatening conditions as FDA puts them on a fast-track approval process and gives the drug manufacturers intensive guidance. The approval for Bristol-Myers’ combination therapy of chronic HCV infection comes after preliminary data from an ongoing late-stage trial in which the drug manufacturer is evaluating an all-oral regimen of daclatasvir and asunaprevir without ribavirin.


Copyright © 2014 -CDC Prevention News Update, Publisher. All rights reserved to Information, Inc., Bethesda, MD. The CDC National Center for HIV, STD and TB Prevention provides the following information as a public service only. Providing synopses of key scientific articles and lay media reports on HIV/AIDS, other sexually transmitted diseases and tuberculosis does not constitute CDC endorsement. This daily update also includes information from CDC and other government agencies, such as background on Morbidity and Mortality Weekly Report (MMWR) articles, fact sheets, press releases and announcements. Reproduction of this text is encouraged; however, copies may not be sold, and the CDC HIV/STD/TB Prevention News Update should be cited as the source of the information. Contact the sources of the articles abstracted below for full texts of the articles.

Information in this article was accurate in February 26, 2014. The state of the art may have changed since the publication date. This material is designed to support, not replace, the relationship that exists between you and your doctor. Always discuss treatment options with a doctor who specializes in treating HIV.