Sarepta (SRPT) Receives FDA Fast Track Designation for Marburg, Ebola Virus Treatments
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Sarepta Therapeutics, Inc. (NASDAQ: SRPT), a developer of innovative RNA-based therapeutics, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track status for the development of its lead infectious disease drug candidates, AVI-7288 and AVI-7537, for the treatment of Marburg virus and Ebola virus, respectively. Sarepta has been developing these platform-based therapeutics under a U.S. Department of Defense (DoD) contract managed by the Joint Project Manager Transformational Medical Technologies (JPM-TMT) Project Management Office, a component of the Joint Program Executive Office for Chemical and Biological Defense (JPEO-CBD).
The FDA's Fast Track program is designed to facilitate the development of, and expedite the review of, new drugs that have shown the potential to address an unmet medical need in a serious or life-threatening disease. Fast Track designated drugs qualify for Priority Review, an expedited review process available to drugs that offer major advances in treatment or provide a treatment where no adequate therapy exists.
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The FDA's Fast Track program is designed to facilitate the development of, and expedite the review of, new drugs that have shown the potential to address an unmet medical need in a serious or life-threatening disease. Fast Track designated drugs qualify for Priority Review, an expedited review process available to drugs that offer major advances in treatment or provide a treatment where no adequate therapy exists.
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