FDA authorizes use of experimental Ebola drug

The Food and Drug Administration (FDA) has approved an experimental drug for fighting the Ebola virus, according to the medication’s Canadian manufacturer.

Tekmira Pharmaceuticals Corp. said it has already begun to administer the agent known as TKM-Ebola in emergency situations under “expanded access protocols” approved by the FDA and corresponding Canadian regulators.

Repeat infusions have been “well tolerated” in numerous patients with confirmed or suspected Ebola cases, said Dr. Mark J. Murray, Tekmira's chief executive.


"Our TKM-Ebola drug supplies are limited, but we will continue to help where we can, as we continue to focus on the other important objectives we have to advance therapies to meet the unmet needs of patients."

An FDA spokeswoman said Tuesday that she was unable to confirm the authorization.

“Federal law and FDA regulations prohibit the agency from sharing information about drugs in development, as it's considered confidential,” Stephanie Yao said. “The company may share information about their product if they wish.”

More than 5,800 Ebola cases have been recorded in six Western African countries, the majority reported in Liberia, Sierra Leone and Guinea, the World Health Organization said this week. More than 350 healthcare workers have contracted the virus, with roughly half of them dying.

Others have returned to their home countries, including the United States, for treatment. It was unclear, however, whether the FDA’s authorization applied only to patients currently in the United States.

The authorization of TKM-Ebola use came via the FDA’s Expanded Access Program, which allows investigational drugs to be administered in life-threatening cases when there “are no comparable or satisfactory alternative treatment options,” Tekmira said.

TKM-Ebola is being developed under a $140 million contract with the U.S. Department of Defense, according to the firm.

News of its use in patients comes as a new data model from the Centers for Disease Control and Prevention predicted Tuesday that he Ebola epidemic could swell to 1.4 million cases by January without additional help to fight the disease.