FDA OKs Ebola Treatment for Emergency Use

Ebola cases in West Africa continue to rise as organizations work to contain the outbreak

/ Author:  / Reviewed by: Joseph V. Madia, MD Beth Bolt, RPh

(RxWiki News) With case estimates as high as 1.4 million by mid-January, the Ebola outbreak continues to spread in West Africa. In response, the US Food and Drug Administration (FDA) approved an Ebola treatment for emergency, limited use.

The FDA approved TKM-Ebola — produced by Tekmira — for emergency use in patients with Ebola virus disease.

TKM-Ebola is still being researched, but the FDA and Health Canada have worked together to approve the treatment for limited use on select patients.

"TKM-Ebola has been administered to a number of patients and the repeat infusions have been well tolerated," said Tekmira CEO Dr. Mark J. Murray, in a press release. "However, it must be kept in mind that any uses of the product under expanded access, does not constitute controlled clinical trials."

The treatment has been studied on primates — it provided "100 percent protection from an otherwise lethal dose of [Ebola]," according to a press release.

The approval to use the treatment comes on the heels of new estimates from the Centers for Disease Control and Prevention (CDC) — adjusting for underreporting, the CDC speculates that Ebola cases in Liberia and Sierra Leone could reach 1.4 million by Jan. 20.

But that's with no additional help from foreign governments and aid groups. As aid ramps up — with recent boosts from 3,000 US troops and 165 Cuban doctors being sent to West Africa — some health officials are hopeful that the worst-case scenario won't come true.

“My gut feeling is, the actions we’re taking now are going to make that worst-case scenario not come to pass,” CDC Director Dr. Thomas R. Frieden told The New York Times. “But it’s important to understand that it could happen.”

Now the worst outbreak of the virus in known history, the West African Ebola outbreak has killed more than 2,800 people, according to a recent editorial published in The New England Journal of Medicine. The Ebola virus can cause Ebola virus disease. This often fatal disease is marked by fever, fatigue and bleeding.

The latest report from the World Health Organization (WHO) says that, among recorded cases of the disease, the fatality rate is 70.8 percent.

Dr. Frieden told CNN that the current virus isn't more deadly than other strains — it's just operating in an environment where it can spread. Overstretched health care systems, densely populated cities and a common distrust of the authorities all add to the virus's ability to spread quickly in West Africa, he said.

The latest WHO report speculates that the number of cases could jump from the current 5,843 to more than 20,000 by Nov. 2 without increased aid from the global community.

And aid has increased in recent weeks. Dr. Frieden told CNN that the recent boost in foreign aid could "break the back of the epidemic." According to the CDC, if 70 percent of Ebola patients receive proper care in medical settings, the epidemic could be stopped.

Review Date: 
September 23, 2014
Last Updated:
October 8, 2014