FDA grants fast track status for two Sarepta drug candidates
The FDA granted the status for the development of the drugs for the Department of Defense. Both the Marburg virus and the Ebola virus are considered biological threats, the Examiner reports.
The Cambridge, Mass.-based company developed the AVI-7288 candidate for the treatment of Marburg virus and the AVI-7537 candidate for the treatment of Ebola virus.
"The FDA recognizes the significant unmet medical need for these highly lethal hemorrhagic fever viruses and the necessity to move the development of these drugs forward as fast as possible to ensure effective medical countermeasures for the warfighter," Chris Garabedian, the president and CEO of Sarepta, said, according to the Examiner. "We believe Sarepta has the only drug candidates for Marburg and Ebola with fast track designation and expect this designation will provide an expedited approval process to help DOD achieve its mission of protecting the nation from biothreats."
The fast track status facilitates the development and an expedited review for drug candidates to treat serious disease and fill a medical need that has not been met. The FDA designation comes after recent outbreaks of Ebola hemorrhagic fever in Uganda and a current outbreak in the Democratic Republic of Congo, according to the Examiner.