Ebola: U.S. under pressure to fast track approval of experimental drugs ‎

Ebola Virus

One of such drugs being proposed is TKM-Ebola manufactured by Tekmira Pharmaceuticals‎.

Following worries that the Ebola virus may become a global health emergency if not contained on time, medical experts have appealed to the Food and Drug Administration (FDA) of the United States of America to accelerate the approval of the human testing of experimental drugs that have proved effective in killing the virus in primates and rodents.

One of such drugs being proposed is TKM-Ebola manufactured by Tekmira Pharmaceuticals said to be highly effective in killing the virus in primate.

A Sierra Leonean born, U.S. based doctor, Ahmed Tejan-Sie, in a petition on Charge.org‎ is asking the FDA to fast track the approval of the drugs and vaccines for Ebola treatment. In the petition, he said the first phase of clinical trial actually started in July before it was put on hold by the FDA.

“In July this year the Food and Drug Administration (FDA) of the United States of America placed a hold on this trial despite the fact that 14 research participants had already safely tolerated the drug,” Mr. Tejan-Sie said.

Mr. Tejan-Sie, who was the best graduating student in medicine, University of Ibadan, in 1991, is an expert in internal medicine and works at the Alamance Regional Medical Center and Duke University Hospital in the U.S.

“Given that at least one patient has transferred the disease from Liberia to Nigeria by air travel, the possibility of a global pandemic becomes increasingly likely.

“There is a precedent for fast tracking anti-Ebola drugs in emergency cases as happened last year when a researcher was exposed to the virus and received an experimental vaccine,” he said.

His petition has so far gathered 39,900 signatures and still needs 13,100 to reach its mark.

Quoting an unnamed FDA source, Reuters reported that human trial of TKM-Ebola was placed on hold following concern that participants in the initial trial experienced “problematic immune responses.”

The source said the FDA could reconsider lifting the hold on the drug if the manufacturer presents a new study proposal, with reduced safety risk.

“Anything that would shift the risk-benefit to a more favourable outcome could potentially allow the authorization of that study,” the source told Reuters.

Another set of drugs and vaccines, which are being developed, will commence testing on humans in early September, the CNN is reporting.

According to the U.S. National Institute of Health (NIH), a vaccine it has been working on for years and found to be effective on primates will be tested in early September and the result of the test likely released early next year.

Not commercial viable

Doctors are also frustrated at the lack of interest by major pharmaceutical companies in developing a drug to treat the virus. The companies are believed to argue that the market for such a drug is too small.


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