Sarepta's Ebola, Marburg virus drugs get FDA fast track status

Tue Sep 18, 2012 10:19am EDT

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(Reuters) - Biotechnology company Sarepta Therapeutics Inc said U.S. health regulators granted fast track status to two of its experimental drugs for the treatment of the Marburg and Ebola viruses.

Shares of the company rose 7 percent to $15.95 on Tuesday morning on the Nasdaq.

A fast track designation by the U.S. Food and Drug Administration expedites regulatory review of drugs that aim to treat serious diseases and fill unmet medical needs.

Data from clinical trials for such drugs can be submitted to the FDA on a rolling basis rather than waiting until pivotal studies are completed.

The Ebola and Marburg viruses are potentially fatal hemorrhagic fevers endemic to parts of Africa. There are no current treatments for the diseases, the company said.

A recent outbreak of the Ebola virus in the Democratic Republic of Congo killed at least 31 people.

Sarepta was developing the hemorrhagic virus drugs under a contract from the U.S. Department of Defense.

The Ebola program is under a temporary stop-work order due to funding constraints, the company said.

(Reporting By Vrinda Manocha in Bangalore; Editing by Sriraj Kalluvila)

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