FDA Approval of Antiretroviral Agents: An Evolving Paradigm

The approach to traditional approval of antiretroviral agents in the United States has recently evolved. As in the past, companies can provide confirmatory clinical endpoint data following accelerated approval; alternatively, they can base their claim of efficacy primarily on data demonstrating a su...

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Bibliographic Details
Published in:Drug information journal 1999, Vol.33 (2), p.337-341
Main Author: Behrman, Rachel E.
Format: Article
Language:English
Subjects:
Antiretroviral agents
Antiretroviral drugs
Clinical trials
Collaboration
Evolution
FDA approval
HIV
Human immunodeficiency virus
Regulatory agencies
Ribonucleic acid
RNA
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Summary:The approach to traditional approval of antiretroviral agents in the United States has recently evolved. As in the past, companies can provide confirmatory clinical endpoint data following accelerated approval; alternatively, they can base their claim of efficacy primarily on data demonstrating a sustained reduction in plasma HIV-1 RNA. This change was fueled by issues associated with conducting long-term clinical endpoint trials given the rapidly changing treatment strategies for HIV and the availability of potent combination regimens. The Food and Drug Administration (FDA) hopes that this new approach will help direct more resources to ambitious, collaborative clinical trials. The rapid evolution of traditional approval also illustrates the importance of close collaboration between industry, academia, and the FDA. This field would not have moved forward so rapidly without consensus initiatives such as the Surrogate Marker Collaborative Group, which provided evidence suggesting that a virologic response, in terms of changes in HIV-1 RNA, is a strong predictor of clinical benefit.
ISSN:2168-4790
0092-8615
2168-4804
2164-9200
DOI:10.1177/009286159903300202