Dive Brief:
- AVI-7537 is an injectable drug developed by Sarepta to treat the Ebola virus.
- Sarepta is receiving support from the U.S. Department of Defense.
- Work on Sarepta’s Ebola drug was put on hold during the fiscal cliff fight of 2012.
Dive Insight:
According to Chris Garabedian, CEO of Sarepta, the company has ‘clinical trial-quality drug’ ready to ship if the government requests it. Currently, Sarepta has enough of the drug to treat approximately 25 patients within the first week, with the capability of ramping up to 100 patients within the coming months. Sarepta’s Ebola drug is covered by two patents, which Sarepta shares with the US Army Medical Research Institute.
It is unclear whether or not the government will approve Sarepta's request given the recent focus on Texas-based Tekmira's TKM-Ebola and Mapp Biopharmaceutical's ZMapp. The FDA has reportedly shifted TKM-Ebola's status to "partial hold," meaning that it can be used on Ebola-infected patients, and ZMapp has already been used as an experimental treatment on two U.S. citizens who were infected with Ebola abroad.
The World Health Organization (WHO) is convening a panel of ethicists to determine the right way to move forward on experimental Ebola drugs, and the Obama administration announced on Thursday that it is forming a special working group to consider broad "principles of decision-making."