U.S. FDA says 'stands ready' to work with companies developing Ebola drugs
By Julie Steenhuysen Reuters
9:47 p.m. EDT, August 1, 2014
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Tekmira's drug has only been tested in a few dozen healthy people. The FDA stopped its study in July because of safety concerns among people taking the highest doses of the drug who experienced problematic immune responses.
The hold means that particular study cannot proceed, but it does not prevent the company from submitting a new study proposal, say in people already infected with Ebola, for whom any safety risks from the treatment would be mitigated by the risk of dying.
In that case, "the benefit-risk ratio changes completely," the FDA source said. "Anything that would shift the risk-benefit to a more favorable outcome could potentially allow the authorization of that study."
What is not clear is whether Tekmira or any developers of possible Ebola treatments would choose to test their drugs in patients infected with Ebola, particularly in the midst of a raging epidemic in which emotions and expectations run high.
Tekmira officials did not return calls or emails on Friday seeking comment. In a July 21 press release, the company said it is "mindful of the need for this important therapeutic in situations such as the ongoing Ebola outbreak in West Africa."
"TKM-Ebola is currently an unapproved agent and the regulatory framework to support its use in Africa has not been established at this time," the company added.
Dr. Thomas Geisbert of the University of Texas Medical Branch has done animal studies on the Tekmira drug and said there are few companies willing to develop Ebola treatments. There is "little financial incentive," given the small market potential for a drug that treats a rare disease afflicting developing countries, he said.
Geisbert said the drug "works great in monkeys in the lab," but that is largely because it is given relatively early in the course of infection.
"What if you start giving it to people who are almost dead and they die, but it's not the drug's fault? Then you blame the drug."
Geisbert said given the widespread mistrust of doctors in West Africa, which has driven dozens of victims to evade treatment, such an event could jeopardize the drug's prospects.
"It's a very delicate situation," he said.
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