FDA approval of Antiretroviral Agents: An Evolving Paradigm
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Drug Informution Journal, Vol. 33, pp. 337-341. 1999 Printed in the USA. All righfs reserved.
Copyright 0 1999 Drug Information Association Inc.
FDA APPROVAL OF ANTIRETROVIRAL AGENTS: AN EVOLVING PARADIGM RACHELE. BEHRMAN, MD, MPH Deputy Director, Office of Drug Evaluation 1, Center for Drug Evaluation and Research, United States Food and DNg Administration, Rockville, Maryland
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 efJicacy primarily on data demonstrating a sustained reduction in plasma HIV- 1 RNA. This change was fueled b y issues associated with conducting long-term clinical endpoint trials given the rapidly changing treatment strategies for HIV and the availability of potent combinarion regimens. The Food and Drug Administrarion (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-I RNA, is a strong predictor of clinical benefit. Key Words: Antiretroviral agents; FDA regulatory requirements; Traditional approval; Viral load reduction
INTRODUCTION THERE HAS BEEN A recent, and dramatic, change in how the FDA approaches approval of antiretroviral agents. Confirmatory clinical endpoint trials are now no longer the only basis on which a company can apply for traditional approval. Demonstrating a sustained suppression of HIV-1 RNA is now also considered an acceptable basis for traditional approval. This evolution of traditional approval occurred in a proactive and timely manner
Presented at the DIA 34th Annual Meeting '"Thinking Globally: Product Development, Registration and Marketing in the New Millennium," June 7-1 l , 1998, Boston, Massachusetts. Reprint address: Dr. Rachel Behrman, Office of Drug Evaluation 1, Center for Drug Evaluation and Research, U S Food w d Drug Administration, 1451 Rockville Pike, Rockville, MD 20857.
and was aided by collaborative effort between European and United States regulatory agencies, industry, and academia. One example of this collaboration was the Surrogate Marker Collaborative Group. This group was responsible for cross-study analyses that demonstrated a correlation between clinical progression rates and changes in HIV- 1 RNA levels.
REGULATORY REQUIREMENTS IN RELATION TO SURROGATE MARKERS Section 505(d) of the Federal Food, Drug and Cosmetics Act (the act) provides FDA with statutory authority to grant marketing approval of a new agent, provided that there is substantial evidence of the therapeutic effect cited in the prescription drug labeling.
