FDA Downgrades Clinical Hold on Experimental Ebola Drug
The FDA has downgraded its clinical hold on Tekmira Pharmaceuticals’ TKM-Ebola experimental RNA interference therapeutic, a move that could clear the way for the drug’s potential use in individuals infected with Ebola virus.
Under a partial clinical hold, however, Tekmira is still prohibited from testing multiple ascending doses of TKM-Ebola in healthy volunteers in its ongoing Phase I trial. The FDA placed a full clinical hold on the trial last month based on concerns of potentially lethal cytokine storms caused by the agent.
Tekmira hinted that the downgrade might allow it to provide its investigational drug to infected individuals currently suffering in West Africa. “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,” Tekmira President and CEO Mark Murray said last week.
To do this, Tekmira would need to receive FDA permission to use the drug under an expanded access program, Kulkarni Darshan of the Kulkarni law firm said. Any expanded use would also have to be authorized by health authorities in the four affected countries, Darshan said, assuming that Tekmira could even manufacture enough of the drug to distribute it widely in Africa.
FDA spokeswoman Stephanie Yao said that the FDA has procedures in place to provide investigational drugs under emergency use, but the agency could not comment on specific products.
The White House said Friday that it was convening a study group to consider ways of distributing experimental Ebola drugs to victims of the virus in Africa. The World Health Organization is set to do the same this week. Earlier last week, President Obama said that no one knows enough about these drugs to say for sure whether they are safe to give to patients.
Meanwhile, the U.S. Centers for Disease Control and Prevention declined to confirm reports that it had denied a Nigerian government request for access to Mapp Biopharmaceutical’s ZMapp monoclonal antibody that was delivered to two ill American missionaries in Liberia. — Lena Freund
Originally appeared in Drug Industry Daily, the pharmaceutical industry’s number one source for regulatory news and information. Click here for more information.