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FDA addresses concerns on approval of drugs to treat chronic hepatitis C

Date:
June 2, 2015
Source:
Wiley
Summary:
Treatment options for chronic hepatitis C, a serious and life-threatening infection, have improved substantially and several new regimens with shorter durations and improved efficacy and safety profiles are now available.
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Treatment options for chronic hepatitis C, a serious and life-threatening infection, have improved substantially and several new regimens with shorter durations and improved efficacy and safety profiles are now available.

Groups have raised concerns about the evidence used to support the approval of some newer drugs, however, and the issue has been used to cast doubt on their efficacy and even to question treatment or deny reimbursement.

To address these concerns, the US Food and Drug Administration's Division of Antiviral Products in the Center for Drug Evaluation and Research (CDER) has published a paper that highlights the agency's scientific approaches and regulatory processes that support the development and approval of promising drugs to treat hepatitis C.

"FDA's approach to evaluation of recent hepatitis C drugs underscores the Agency's flexibility in considering innovative or alternative trial designs for drugs that have demonstrated highly promising outcomes in early phase development," said Dr. Poonam Mishra, deputy director for Safety, Division of Antiviral Products/Office of Antimicrobial Products in the FDA's Center for Drug Evaluation and Research and lead author of the Hepatology paper. "Expedited approaches can be used without compromising efficacy standards for drugs that demonstrate breakthrough therapy potential."


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Materials provided by Wiley. Note: Content may be edited for style and length.


Journal Reference:

  1. Poonam Mishra, Jeffrey Murray, Debra Birnkrant. Direct-acting antiviral drug approvals for treatment of chronic hepatitis C virus infection: Scientific and regulatory approaches to clinical trial designs. Hepatology, 2015; DOI: 10.1002/hep.27880

Cite This Page:

Wiley. "FDA addresses concerns on approval of drugs to treat chronic hepatitis C." ScienceDaily. ScienceDaily, 2 June 2015. <www.sciencedaily.com/releases/2015/06/150602093024.htm>.
Wiley. (2015, June 2). FDA addresses concerns on approval of drugs to treat chronic hepatitis C. ScienceDaily. Retrieved May 23, 2017 from www.sciencedaily.com/releases/2015/06/150602093024.htm
Wiley. "FDA addresses concerns on approval of drugs to treat chronic hepatitis C." ScienceDaily. www.sciencedaily.com/releases/2015/06/150602093024.htm (accessed May 23, 2017).

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