FDA Upgrades Hold on Trial Drug as WHO Declares Ebola Outbreak an International Health Emergency

Davy James, Associate Editor
Published Online: Friday, August 8, 2014
Follow Pharmacy_Times:
Clinical hold on Tekmira’s Ebola treatment changed to partial hold by the FDA.
As new treatments loom on the horizon, the escalating Ebola virus outbreak in West Africa prompted the World Health Organization (WHO) to declare the epidemic an international health emergency today.

In response to the outbreak in 4 West African countries, WHO conducted an emergency meeting earlier this week to discuss the implementation of control strategies and current gaps in the response to the disease. Following deliberation, WHO declared the outbreak constitutes an “extraordinary event” and a public health risk to other states with a consequential international response necessary to prevent the further spread of the virus internationally.

The latest figures on the crisis released by WHO place the estimated death toll at nearly 1000, with more than 1700 confirmed and suspected cases. Due to fragile health systems with deficits in both financial and human resources, WHO is advising leaders of regions affected by Ebola to coordinate effective national emergency disaster response measures for a comprehensive containment plan.

“States should ensure that there is a large-scale and sustained effort to fully engage the community–through local, religious and traditional leaders and healers–so communities play a central role in case identification, contact tracing, and risk education,” WHO said in a press release. “The population should be made fully aware of the benefits of early treatment.”
 
As the international community coordinates efforts to fight the spread of the virus through public health measures, research on vaccines to slow down or stop Ebola entirely continues. WHO is set to conduct an ethical meeting next week to discuss the use of ZMapp, an experimental drug which showed promising results after being administered in Ebola-stricken American relief workers Dr. Kent Brantly and Nancy Writebol.

Meanwhile, the FDA changed the clinical hold on Tekmira Pharmaceuticals Corp’s experimental vaccine, TKM-Ebola, to a partial hold on Thursday. The drug was in a Phase I clinical trial before the study was halted on July 3, 2014.

Upgrading the hold allows for the potential use of TKM-Ebola to treat patients infected with the virus, the FDA said.

"We are pleased that the FDA has considered the risk-reward of TKM-Ebola for infected patients,” said Mark Murray, PhD, CEO and President of Tekmira Pharmaceuticals, in a press release. “We have been closely watching the Ebola virus outbreak and its consequences, and we are willing to assist with any responsible use of TKM-Ebola. The foresight shown by the FDA removes one potential roadblock to doing so."

The clinical hold was initially put in place so Tekmira could provide a review of the data from the single ascending dose portion of the trial, before it proceeded to the multiple ascending dose phase.

“We are focused on an expedient resolution of this so that we can advance our TKM-Ebola to evaluate the multiple ascending dose regimen," Dr. Murray said.

Related Articles
Thousands of US military personnel will deploy to West Africa.
Using a less market-oriented payment scheme could reduce high hospital administrative costs.
Current transmission rates from primary cases to secondary cases could cause Ebola epidemic to explode.
Involving pharmacists in the intensive care unit reduces adverse events and costs for patients who receive continuous veno-venous hemofiltration.
Latest Issues
$auto_registration$